Neoplasms

All Conditions

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Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

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Anti-Infective Agents

Vitamins

Amino Acids

Pembrolizumab

Paclitaxel

Docetaxel

Albumin-Bound Paclitaxel

Oxaliplatin

Bevacizumab

Atezolizumab

Carboplatin

Leucovorin

Fluorouracil

Irinotecan

Pemetrexed

Everolimus

Palbociclib

Afatinib

Trametinib

Sotorasib

Panitumumab

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Immune Checkpoint Inhibitors

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Immunosuppressive Agents

Immunologic Factors

Tyrosine Kinase Inhibitors

Folinic Acid

Folate

Vitamin B9

Tyrosine

Experimental: Sotorasib + trametinib + panitumumab Dose Exploration and Dose Expansion

* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors.
* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors.

Experimental: Sotorasib + RMC-4630 Dose Exploration and Dose Expansion

* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors.
* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants, with KRAS p.G12C mutant advanced solid tumors.

Experimental: Sotorasib + afatinib Dose Exploration and Dose Expansion

* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer.
* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer.

Experimental: Sotorasib + panitumumab +/- chemotherapy Dose Exploration and Dose Expansion

* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced colorectal cancer.
* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors.

Experimental: Sotorasib + atezolizumab Dose Exploration and Dose Expansion

* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer.
* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer.

Experimental: Sotorasib + carboplatin, pemetrexed, docetaxel, paclitaxel, pembrolizumab Dose Exploration and Dose Expansion

* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer.
* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer.

Experimental: Sotorasib only Dose Exploration and Dose Expansion

* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer with brain metastases.
* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer with brain metastases.

Experimental: Sotorasib + palbociclib Dose Exploration and Dose Expansion

* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced solid tumor.
* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumor.

Experimental: Sotorasib + pembrolizumab Dose Exploration and Dose Expansion

* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant non small cell lung cancer.
* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS P.G12C mutant non small cell lung cancer.

Experimental: Sotorasib + MVASI® (bevacizumab-awwb)+ chemotherapy Dose Exploration and Dose Expansion

* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced colorectal cancer.
* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced colorectal cancer.

Experimental: Sotorasib + TNO155 Dose Exploration and Dose Expansion

* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors.
* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors.

Experimental: Sotorasib + BI 1701963 Dose Exploration and Dose Expansion

* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors.
* Upon completion of dose exploration part of the study the dose expansion cohort is for eligible participants with KRAS P.G12C mutant advanced non-small cell lung cancer and advanced colorectal cancer.

Experimental: Sotorasib + AMG 404 Dose Exploration and Dose Expansion • Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors. • Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors

Experimental: Sotorasib + everolimus Dose Exploration and Dose Expansion • Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced solid tumor. • Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumor.

Sotorasib administered orally as a tablet.

Trametinib administered orally as a tablet.

RMC-4630 administered orally as a capsule.

RMC-4630

afatinib administered orally as a tablet.

pembrolizumab administered as an intravenous (IV) infusion.

Panitumumab administered as an IV infusion.

Carboplatin, pemetrexed, docetaxel administered as an IV infusion.

Carboplatin, pemetrexed, docetaxel, paclitaxel

Atezolizumab administered as an IV injection.

Palbociclib administered orally as a tablet.

MVASI® (bevacizumab-awwb) administered as an IV infusion.

MVASI® (bevacizumab-awwb)

TNO155

Chemotherapy combination of leucovorin administered as an IV injection, 5-fluorouracil (5-FU) administered as IV bolus injection or IV continuous infusion (depending on dose), and irinotecan administered as IV injection.

IV Chemotherapy (Regimen 1)

IV chemotherapy combination of leucovorin administered as an IV injection, 5-FU administered as IV bolus injection or IV continuous infusion (depending on dose), and oxaliplatin administered as IV injection.

IV Chemotherapy (Regimen 2)

BI 1701963

AMG 404

Amgen Call Center

To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors.

Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

A Phase 1b, Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Sotorasib Monotherapy and in Combination With Other Anti-cancer Therapies in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Intracranial objective response rate assessed per Response Assessment in Neuro-oncology Brain Metastases (RANO-BM).

Intracranial disease control rate assessed per RANO-BM.

Intracranial duration of response assessed per RANO-BM.

Non-intracranial PFS assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

Overall PFS assessed per RECIST 1.1 and RANO-BM.

Amgen

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Pharmaceutical Solutions

Channel Blockers

Herbal and Botanical

Tislelizumab

Dabrafenib

Spartalizumab

Gallopamil

Naporafenib

Cola

dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer

dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer - Arm is closed for further enrollment.

LTT462

LXH254

Liquid in vial (Concentrate for solution for infusion) for intravenous use

Novartis Pharmaceuticals

A phase Ib, open-label platform study of select drug combinations chosen in order to characterize safety and tolerability of each treatment arm tested and to identify recommended doses and regimens for future studies.

This is a phase Ib, multi-center, open-label study with multiple treatment arms in adult patients with advanced or metastatic BRAF V600 (E, D, or K) in order to characterize safety and tolerability of each treatment arm tested and to identify recommended doses and regimens for future studies. The open platform design of this study is adaptive to allow removal of combination treatment arm(s) based on emerging data and facilitate introduction of new candidate combinations. The study is comprised of a dose escalation part and may be followed by a dose expansion part for any combination treatment arm.

A Study of Select Drug Combinations in Adult Patients With Advanced/Metastatic BRAF V600 Colorectal Cancer

A Phase Ib, Multicenter, Open-label Dose Escalation and Expansion Platform Study of Select Drug Combinations in Adult Patients With Advanced or Metastatic BRAF V600 Colorectal Cancer

To characterize safety and tolerability of each treatment arm tested and identify recommended doses (RD) and regimens for future studies

To characterize safety and tolerability of each treatment arm tested and identify recommended doses and regimens for future studies

To characterize the PK of each investigational drug within each treatment arm

To evaluate preliminary anti-tumor activity of each treatment arm per RECIST v1.1.

To evaluate PD effect in their respective combinations in tumor

Respiratory Tract (Lung and Bronchial) Diseases

Blood and Lymph Conditions

Immune System Diseases

Lung Neoplasms

Lymphoma

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Lymphosarcoma

Crizotinib

* The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits.
* Phase 1 (the dose-finding portion of the study) will follow a standard 3+3 design. Enrollment to the different study arms will occur in parallel.

  * Lorlatinib will be administered orally once daily at a predetermined dose for 28 days
  * Crizotinib will be administered orally twice daily at a predetermined dose for 28 days
* Phase II patients will be treated with Lorlatinib and Crizotinib at a dose recommended based on the phase I study.

* The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits.
* The phase I part of the study will follow a standard 3+3 design. Enrollment to the different study arms will occur in parallel.

  * Lorlatinib will be administered orally once daily at a predetermined dose for 28 days
  * Binimetinib will be administered orally twice daily at a predetermined dose for 28 days.
* Phase II patients will be treated with Lorlatinib + Binimetinib at a dose recommended based on the phase I study.

* The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits.
* The phase I part of the study will follow a standard 3+3 design. Enrollment to the different study arms will occur in parallel.

  * Lorlatinib will be administered orally once daily at a predetermined dose for 21 days
  * TNO155 will be administered orally once daily at a predetermined dose for 14 out of 21 days.
* Phase II patients will be treated with Lorlatinib + TNO155 at a dose recommended based on the phase I study.

Lorlatinib will be taken orally once daily for 28 days when combined with crizotinib or binimetinib. Lorlatinib will be taken orally once daily for 21 days when combined with TNO155.

Crizotinib taken orally twice daily for 28 days.

Lorlatinib

Crizotinib will be taken orally twice daily for 28 days.

Binimetnib taken orally twice daily for 28 days.

Binimetinib will be taken orally twice daily for 28 days.

Binimetinib

TNO155 will be taken orally once daily for 14 days.

Ibiayi Dagogo-Jack, MD

Elizabeth Kennedy

Ibiayi Dagogo-Jack

Daniel Costa, MD

This research study is evaluating Lorlatinib in combination with Crizotinib, Binimetinib, or TNO155 as a possible treatment for either anaplastic lymphoma kinase (ALK)-positive lung cancer or ROS1-positive lung cancer.

* This research study involves four study drugs.
* Lorlatinib
* Binimetinib
* Crizotinib
* TNO155

This is a Phase I/II clinical trial of three investigational combinations for treatment of either anaplastic lymphoma kinase (ALK)-positive or ROS1-positive lung cancer. The three drug combinations being tested are (1) Lorlatinib combined with Crizotinib and (2) Lorlatinib combined with Binimetinib and (3) Lorlatinib combined with TNO155.

* Lorlatinib is an oral ALK and ROS1 inhibitor. The US Food and Drug Administration (FDA) has approved Lorlatinib for treatment of ALK-positive lung cancer. The FDA has not approved Lorlatinib for treatment of ROS1-positive lung cancer.
* Crizotinib is an oral ALK and MET inhibitor. The FDA has approved Crizotinib for treatment of ALK-positive lung cancer. Crizotinib is not approved by the FDA for the treatment of MET-positive lung cancer. This study will test crizotinib's ability to block MET signaling. Crizotinib is not approved by the FDA for treatment of ROS1-positive lung cancer.
* Binimetinib is an oral MEK inhibitor. The FDA has not approved binimetinib for treatment of ALK-positive or ROS1-positive lung cancer but it has been approved for other uses.
* TNO155 is an oral SHP2 inhibitor. The FDA has not approved TNO155 for the treatment of any disease, including ALK-positive or ROS1-positive lung cancer. It is an investigational drug.
* The FDA has not approved the combination of Lorlatinib with Binimetinib, Crizotinib, or TNO155 as a treatment for any disease.

The research study procedures include screening for eligibility and study treatment which will include evaluations and follow up visits.

* Patients will undergo screening and those who fulfill the eligibility criteria will be assigned to receive either the combination of Lorlatinib and Crizotinib, the combination of Lorlatinib and Binimetinib, or the combination of Lorlatinib and TNO155. Patients with ALK-positive or ROS1-positive lung cancer who have extra copies of the MET growth signal (MET amplification) will be assigned to receive the Lorlatinib and Crizotinib combination. All other patients will be randomly assigned to receive one of the combinations.
* This study consists of 2 parts:

  * Phase I:

    * The investigators are looking to determine whether combining Lorlatinib with either Binimetinib, Crizotinib, or TNO155 is well tolerated and to understand how treatment with the two drugs affects cancer cells and impacts growth signals.
    * Not everyone who participates in this research study will receive the same dose of the study drug. The dose given will depend on the number of participants who have been enrolled in the study prior and how well the dose was tolerated.
  * Phase II:

    * The Phase II study will test the safest doses of the combinations (as established in the Phase I study) in a larger group of patients.
    * It is expected that about 96 people will take part in this research study

Lorlatinib Combinations in Lung Cancer

A Phase IB/II Study of Lorlatinib Combinations in Anaplastic Lymphoma Kinase-Rearranged Lung Cancer

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

The highest dose of the combinations that does not cause unacceptable side effects. The maximum tolerated dose is determined in clinical trials by testing increasing doses in different groups of patients until the highest dose with acceptable side effects is found.

Objective response rate (partial and complete responses) will be evaluated according to RECIST v1.1 criteria.

Number of patients with treatment-related side effects, according to CTCAE v5.0

PFS will defined as the time from the start of treatment to the date of the first documented progression or death due to disease. The distribution of PFS will be estimated using the Kaplan-Meier method.

Duration of response to treatment is measured from the time that measurement criteria (RECIST v1.1) are met for complete response or partial response (whichever is recorded first) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started), or death due to any cause.

Array BioPharma

Pfizer

Massachusetts General Hospital

Principal Investigator

Symptoms and General Pathology

Carcinoma

Carcinoma, Non-Small-Cell Lung

Neoplasm Metastasis

Neoplasms, Glandular and Epithelial

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antibodies

Immunoglobulins

JDQ443 in combination with TNO155 and tislelizumab

JDQ443

tislelizumab

Obi Okafor

Conor E. Steuer

Rebecca Heist

Teresa Song

Rachel Sanborn

Lorenzo Sellitto

Timothy Burns

Shari A Daniels

Marcelo Vailati Negrao

This is a phase Ib/II open label study. The escalation part will characterize the safety and tolerability of JDQ443 single agent and JDQ443 in combination with the other study treatments (TNO155 and tislelizumab) in advanced solid tumor patients. After the determination of the maximum tolerated dose / recommended dose for a particular treatment arm, dose expansion will assess the anti-tumor activity and further assess the safety, tolerability, and PK/PD of each regimen at the maximum tolerated dose / recommended dose or lower dose.

Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation

A Phase Ib/II Open-label, Multi-center Dose Escalation Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment

All information obtained on AE will be displayed by treatment group. Summary tables will include only AEs that started/worsened during the cycles of treatment (treatment-emergent AEs).

Tolerability of study drug will be assessed by summarizing the number of and reason for dose delays and dose reductions.

Dose intensity is defined as the ratio of actual cumulative dose received and actual duration of treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)	NCT04185883	Advanced Solid ... Kirsten Rat Sar...	Sotorasib Trametinib RMC-4630 Afatinib Pembrolizumab Panitumumab Carboplatin, pe... Atezolizumab Palbociclib MVASI® (bevaciz... TNO155 IV Chemotherapy... IV Chemotherapy... BI 1701963 AMG 404 Everolimus	18 Years - 100 Years	Amgen
A Study of Select Drug Combinations in Adult Patients With Advanced/Metastatic BRAF V600 Colorectal Cancer	NCT04294160	BRAF V600 Color...	Dabrafenib LTT462 Trametinib LXH254 TNO155 Spartalizumab Tislelizumab	18 Years -	Novartis
Lorlatinib Combinations in Lung Cancer	NCT04292119	Lung Cancer Anaplastic Lymp... ROS1 Rearrangem... Relapsed Cancer MET Amplificati... Resistant Cance... NSCLC	Lorlatinib Crizotinib Binimetinib TNO155	18 Years -	Massachusetts General Hospital
Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)	NCT04185883	Advanced Solid ... Kirsten Rat Sar...	Sotorasib Trametinib RMC-4630 Afatinib Pembrolizumab Panitumumab Carboplatin, pe... Atezolizumab Palbociclib MVASI® (bevaciz... TNO155 IV Chemotherapy... IV Chemotherapy... BI 1701963 AMG 404 Everolimus	18 Years - 100 Years	Amgen
Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation	NCT04699188	KRAS G12C Mutan... Carcinoma, Non-... Carcinoma, Colo... Cancer of Lung Cancer of the L... Lung Cancer Neoplasms, Lung Neoplasms, Pulm... Pulmonary Cance... Pulmonary Neopl...	JDQ443 TNO155 tislelizumab	18 Years -	Novartis

Spots Global Cancer Trial Database for tno155

Every month we try and update this database with for tno155 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tno155

Every month we try and update this database with for tno155 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tno155 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.