Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Sarcoma

Thoracic Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Osimertinib

Mitogens

Sotorasib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Tyrosine

ERAS-007 will be orally administered in combination with osimertinib to study participants with EGFRm NSCLC in sequential ascending doses until unacceptable toxicity, disease progression, or withdrawal of consent.

ERAS-007 will be orally administered in combination with sotorasib to study participants with KRAS G12Cm NSCLC in sequential ascending doses until unacceptable toxicity, disease progression, or withdrawal of consent.

ERAS-601 will be orally administered in combination with sotorasib to study participants with KRAS G12Cm NSCLC in sequential ascending doses until unacceptable toxicity, disease progression, or withdrawal of consent.

ERAS-007 will be orally administered at the recommended dose (as determined from Part 1) in combination with osimertinib to study participants with EGFRm NSCLC.

ERAS-007 will be orally administered at the recommended dose (as determined from Part 2) in combination with sotorasib to study participants with KRAS G12Cm NSCLC.

ERAS-601 will be orally administered at the recommended dose (as determined from Part 3) in combination with sotorasib to study participants with KRAS G12Cm NSCLC.

ERAS-007

ERAS-601

Joyce Antal

* To evaluate the safety and tolerability of escalating doses of ERAS-007 or ERAS-601 in combination with other cancer therapies in study participants with advanced non-small cell lung cancer (NSCLC).
* To determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) of ERAS-007 or ERAS-601 administered in combination with other cancer therapies.
* To evaluate the antitumor activity of ERAS-007 or ERAS-601 in combination with other cancer therapies.
* To evaluate the PK profiles of ERAS-007 or ERAS-601 and other cancer therapies when administered in combination.

This is a Phase 1b, open-label, multicenter master protocol evaluating safety, tolerability, and antitumor activity of ERAS-007 or ERAS-601 in combination with other cancer therapies in study participants with advanced NSCLC. The study will commence with the following dose escalation cohorts: ERAS-007 plus osimertinib in study participants with advanced NSCLC harboring epidermal growth factor receptor-sensitizing mutation(s) (EGFRm); ERAS-007 or ERAS-601 plus sotorasib in study participants with advanced NSCLC harboring Kirsten rat sarcoma G12C mutation (KRAS G12Cm). Dose expansion will follow and will evaluate ERAS-007 or ERAS-601 drug combinations administered at the RD identified from each respective dose escalation cohort in study participants with advanced EGFRm or KRAS G12Cm NSCLC.

A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Advanced NSCLC

A Phase 1b Master Protocol of Agents Targeting the Mitogen-Activated Protein Kinase Pathway in Patients With Advanced Non-Small-Cell Lung Cancer

Incidence and severity of treatment-emergent AEs and serious AEs

Maximum plasma concentration of ERAS-007 or ERAS-601 and other cancer therapies

Time to achieve maximum plasma concentration of ERAS-007 or ERAS-601 and other cancer therapies

Area under the plasma concentration-time curve of ERAS-007 or ERAS-601 and other cancer therapies

Half-life of ERAS-007 or ERAS-601 and other cancer therapies

Based on assessment of radiographic imaging per RECIST version 1.1

Erasca, Inc.

Digestive System Diseases

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Diseases

Small Intestinal Adenocarcinoma

Oxaliplatin

Capecitabine

Panitumumab

Starting Dose of Panitumumab: 9 mg/kg by vein over 60 minutes on day 1 of a 14 day cycle.

Starting Dose Level: 9 mg/kg by vein over 60 minutes on day 1 of a 14 day cycle.

Michael Overman, MD

The goal of this clinical research study is to learn if panitumumab can help to control advanced cancer of the small bowel or ampulla of Vater. The safety of this drug will also be studied.

Panitumumab is designed to "turn off" a protein that is important in cell growth. This may stop the growth of cancer cells.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive the study drug during 14 day study "cycles."

On Day 1 of every cycle, you will receive panitumumab by vein over about 60-90 minutes.

Study Visits:

On or before Day 1 of each cycle:

* You will have a physical exam, including measurement of your weight.
* Your performance status will be recorded.
* You will be asked about any symptoms you may be experiencing and any drugs you may be taking.
* Blood (about 2 tablespoons) will be drawn for routine tests.

Every 4 cycles:

* You will have a chest X-ray or a computed tomography (CT) scan of your chest to check the status of the disease.
* You will have a CT or MRI scan to check the status of the disease. If your scan shows that you are responding to the treatment, you will have another CT or MRI scan 6 weeks later.

Length of Study:

You may continue receiving the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse or intolerable side effects occur.

End-of-Treatment:

After you stop taking the study drugs for any reason, you will have an end-of-treatment visit. The following tests and procedures will be performed:

* You will have a physical exam, including measurement of your weight.
* Your performance status will be recorded.
* You will be asked about any symptoms you may be experiencing and any drugs you may be taking.
* Blood (about 2 tablespoons) will be drawn for routine tests.
* If the doctor thinks it is needed, you will have a CT or MRI scan of the abdomen and pelvis to check the status of the disease.

Follow-Up:

Thirty (30) days after your last dose of study drug(s), you will be asked about any symptoms you may be experiencing and any drugs you may be taking. If you are unable to come to MD Anderson for this, the study staff will call you and ask you these questions. This call will last about 30 minutes.

You will then be called every 3 months and asked the same questions. Each call will last about 15-30 minutes.

If you are taken off study treatment for reasons other than the disease getting worse, you will have a CT or MRI scan of the abdomen and pelvis to check the status of the disease every 12 weeks (+/- 2 weeks) after the End-of-Treatment visit. This will be done until the disease gets worse and if you do not start any other anti-cancer treatment.

This is an investigational study. Panitumumab is commercially available and FDA approved to treat a certain type of colorectal cancer. Its use in this type of cancer is investigational.

Up to 27 patients will take part in this study. All will be enrolled at MD Anderson.

CAPOX in KRAS Wild-Type Advanced Adenocarcinoma of the Small Bowel or Ampulla of Vater

Phase II Study of Panitumumab in KRAS Wild-type Locally Advanced or Metastatic Adenocarcinoma of the Small Bowel or Ampulla of Vater

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Time interval in months from date of first treatment until the date of first documented progression of participants.

Amgen

M.D. Anderson Cancer Center

Capecitabine 750mg/m2 oral twice daily, Days 1 - 14 and Panitumumab 9 mg/kg IV over 60 minutes on Day 1 and Oxaliplatin 130 mg/m2 IV over 2 hours Day 1 of 21-day cycle.

Capecitabine + Panitumumab + Oxaliplatin

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Michael J Overman/ Professor, GI Medical Oncology

Response Rate (RR)

Overall Progression-free Survival (PFS) for CAPOX and Panitumumab

Overall Study

Subjects will be given a one-time infusion of AFNT-211 starting at dose level 1 and monitored for 28 days (DLT period). Each cohort will enroll 2-4 subjects at different dose levels for a total of 20 subjects in the escalation portion. The optimal biological dose and recommended phase 2 dose will be determined.

20 subjects with pancreatic ductal adenocarcinoma will be given a one-time infusion of AFNT-211 at the optimal biological dose / recommended phase 2 dose determined in the escalation portion. Subjects will be monitored for safety for 28 days.

20 subjects with colorectal carcinoma will be given a one-time infusion of AFNT-211 at the optimal biological dose / recommended phase 2 dose determined in the escalation portion. Subjects will be monitored for safety for 28 days.

20 subjects with non-small cell cancer will be given a one-time infusion of AFNT-211 at the optimal biological dose / recommended phase 2 dose determined in the escalation portion. Subjects will be monitored for safety for 28 days.

20 subjects with solid tumors will be given a one-time infusion of AFNT-211 at the optimal biological dose / recommended phase 2 dose determined in the escalation portion. Subjects will be monitored for safety for 28 days.

AFNT-211

Shaunica Mitchell

Binaish Khan

Xiomara Menendez

Heinz-Josef Lenz

Chris Hannigan

Joel R Hecht, MD

Salman Punekar, MD

Sophie Hieronymi

Adam Schoenfeld, MD

Rom S Leidner, MD

Megan Barrett

Meredith Pelster, MD

This study is open to adult patients with solid tumors who have a KRAS G12V mutation. This mutation is often found in non-small cell lung cancer (NSCLC), colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC) and other cancers. The study is for patients whose cancer has spread through the body and for whom previous treatments were not successful or treatment does not exist. Patients must also be positive for HLA-A\*11:01. The purpose of this study is to find the best dose of AFNT-211 that is safe and can shrink tumors in patients. AFNT-211 is an investigational therapy and this is the first time that AFNT-211 is being administered to patients. AFNT-211 is an autologous T cell product which means that it is made from a patient's own T cells. These cells are engineered and grown to recognize the KRAS G12V protein on the cell surface of cancer cells. AFNT-211 is infused into patients after a short course of lymphodepleting chemotherapy. Patients will frequently visit the study site. The doctors there will regularly check the size of the cancer and the patient's health. They will also take note of any unwanted effects. Patients may continue in this study for as long as they benefit from the treatment.

AFNT-211 is a cellular therapy consisting of autologous CD4+ and CD8+ T cells engineered to express a human leukocyte antigen-A (HLA-A)\*11:01-restricted Kirsten rat sarcoma (KRAS) G12V-specific transgenic T cell receptor (TCR), the wildtype CD8α/β coreceptor, and a FAS-41BB switch receptor. AFNT-211 is being developed by Affini-T Therapeutics, Inc. (hereafter, "the Sponsor") for the treatment of patients with malignant solid tumors. The primary purpose of this study is to assess the safety and tolerability of AFNT-211 in subjects who are HLA-A\*11:01 positive with advanced or metastatic cancers that harbor a KRAS G12V mutation, as well as determine the optimal biological dose (OBD) and recommended Phase II dose (RP2D) of AFNT-211 in this population. This study will also evaluate the preliminary anti-tumor activity of AFNT-211.

This is a Phase I, FIH, multicenter, open-label study of AFNT-211 consisting of a dose escalation part and a dose expansion part. During dose escalation the optimal biological dose (OBD) will be determined as well as the recommended phase 2 dose (RP2D). Additional subjects will enroll in expansion cohorts treated at OBD/RP2D found in escalation.

Phase I Study of Autologous CD8+ and CD4+ Engineered T Cell Receptor T Cells in Subjects With Advanced or Metastatic Solid Tumor

Quantify the desirability of a dose in terms of toxicity-efficacy tradeoff during the dose escalation portion of the study

This will be selected based on Bayesian optimal interval Phase I/II (BOIN12) design recommendation and the totality of benefit-risk evidence during dose escalation

The incidence of TEAEs will be used to determine safety and tolerability of AFNT-211

The incidence of SAEs will be used to determine safety and tolerability of AFNT-211

The incidence of DLTs during Dose Escalation will be used to determine safety and tolerability of AFNT-211

Percentage of subjects who achieved partial response (PR) or complete response (CR) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Time from first documentation of response of PR or better to first documentation of disease progression or death from any cause, whichever occurs first.

From enrollment to first documentation of disease progression or death of any cause, whichever occurs first.

Time from first AFNT-211 infusion to first documentation of PR or better.

Percentage of subjects who have achieved PR or CR, or had stable disease (SD) for 6 months or more.

From time of enrollment to death from any cause

Affini-T Therapeutics, Inc.

Treatment with GH35 alone, conducted until disease progression, intolerance or end of study.

GH35 for oral administration at doses of Dose A, Dose B, Dose C, Dose D, Dose E and Dose F.

GH35 Tablet

Baohui Han, Professor

Evaluate the safety and tolerability of GH35 in patients with KRAS mutant advanced solid tumors.

Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in patients with KRAS mutant advanced solid tumors.

Dose Finding Study of GH35 in Patients With Advanced Solid Tumors

A Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Primary Antitumor Activity of GH35 in Patients With Advanced Solid Tumors With KRAS Mutation

Number of participants with dose limiting toxicities (DLTs)

Number of participants with treatment-emergent adverse events

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Advanced NSCLC	NCT04959981	Advanced Non-sq...	ERAS-007 ERAS-601 Osimertinib Sotorasib	18 Years - 99 Years	Erasca, Inc.
A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Advanced NSCLC	NCT04959981	Advanced Non-sq...	ERAS-007 ERAS-601 Osimertinib Sotorasib	18 Years - 99 Years	Erasca, Inc.
CAPOX in KRAS Wild-Type Advanced Adenocarcinoma of the Small Bowel or Ampulla of Vater	NCT01202409	Gastrointestina...	Panitumumab	18 Years -	M.D. Anderson Cancer Center
Phase I Study of Autologous CD8+ and CD4+ Engineered T Cell Receptor T Cells in Subjects With Advanced or Metastatic Solid Tumor	NCT06105021	Pancreatic Duct... Non-Small Cell ... Colorectal Canc... Solid Tumor KRAS G12V	AFNT-211	18 Years -	Affini-T Therapeutics, Inc.
Dose Finding Study of GH35 in Patients With Advanced Solid Tumors	NCT05010694	AdvAdvanced Sol... Kirsten Rat Sar...	GH35 Tablet	18 Years -	Suzhou Genhouse Bio Co., Ltd.
A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Advanced NSCLC	NCT04959981	Advanced Non-sq...	ERAS-007 ERAS-601 Osimertinib Sotorasib	18 Years - 99 Years	Erasca, Inc.
Dose Finding Study of GH35 in Patients With Advanced Solid Tumors	NCT05010694	AdvAdvanced Sol... Kirsten Rat Sar...	GH35 Tablet	18 Years -	Suzhou Genhouse Bio Co., Ltd.

Spots Global Cancer Trial Database for kirsten rat sarcoma