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.

Dose Escalation: Oral dose of RLY-1971 until Maximum Tolerated Dose (MTD), and Recommended Phase 2 dose (RP2D) are identified

Dose Expansion: Oral dose of RLY-1971 once Maximum Tolerated Dose (MTD), and Recommended Phase 2 Dose (RP2D) are identified.

RLY-1971

Clinical Trials

This study is a multi-center, open-label, dose escalation and expansion study of RLY-1971 in subjects with advanced or metastatic solid tumors.

Dose escalation/dose expansion study to assess the MTD, safety, tolerability, PK and preliminary anti-tumor activity of RLY-1971. Approximately 70 patients

RLY-1971 in Subjects With Advanced or Metastatic Solid Tumors

Phase 1, Open Label, Dose Escalation and Expansion Study of RLY-1971, a Highly Potent and Selective SHP2 Inhibitor, in Subjects With Advanced or Metastatic Solid Tumors

Blood will be collected at pre-dose at baseline on Cycle 1, Day 1 (C1D1) and at 3 time points (pre-dose, 2 hours post-dose, and 4 hours post-dose) on Cycle 1, Day 15 (C1D15) to assess the extent of target engagement

Blood will be collected at screening and at End of Treatment on all patients

DOR is defined as the time from the participant's initial objective response (CR or PR) to RLY-1971, to disease progression or death due to any cause, whichever occurs first

PFS is defined as the time from the start of study treatment to the first documented disease progression per RECIST v1.1, or death due to any cause, whichever occurs first

MTD is defined as a dose level immediately below that at which ≥2 of 6 subjects experience a DLT during the first cycle.

RP2D may be the same dose level or lower than the determined MTD.

Blood samples may be taken at pre-dose, 0.5, 1, 2, 4, 6, and 8hrs on Cycle 1 Day 1 and 15, 24 hrs post dose on Cycle 1 Day 2, and pre-dose on Cycle 2 Day 1

Evaluation by RECIST 1.1; ORR is defined as the proportion of subjects in the response evaluable population who achieve the best overall response (BOR) of CR or PR

DCR is defined as the percentage of response evaluable subjects who achieve a BOR of CR, PR or SD for at least 3 months

Hoffmann-La Roche

Digestive System Diseases

Esophageal Neoplasms

Head and Neck Neoplasms

Esophageal Cancer

JAB-3068 will be orally administered on a daily basis. Patients need to fast 2 hours before （6 hours for PK days) and 2 hours after each dosing.

JAB-3068

Jacobio Pharmaceuticals

Kelly Mozzetta

Gerald S Falchook, MD

Katie Hanchey

Judy Wang, M.D.

Kayla Karan

Todd M Bauer, MD

Sarina A. Piha-Paul, MD

This is a phase 1, multi-center, dose escalation, open-label study to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of JAB-3068 in adult patients with advanced solid.

A First in Human, Dose Escalation Study of JAB-3068 （SHP2 Inhibitor） in Adult Patients With Advanced Solid Tumors

A Phase 1, Multi-Center, Dose Escalation, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-3068 in Adult Patients With Advanced Solid Tumors

On treatment versus baseline comparison of pharmacodynamic marker pERK (Phosphorylated form of Extracellular signal-regulated kinase) on newly obtained tumor biopsy samples by IHC.

Incidence of dose limiting toxicities (DLTs) in the dose escalation phase. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first treatment cycle with JAB-3068.

All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms, cardiac imaging and ophthalmological assessments

Area under the plasma concentration time curve of JAB-3068

Highest observed plasma concentration of JAB-3068

Time of highest observed plasma concentration of JAB-3068

ORR is defined as the proportion of participants with complete response or partial response (CR+PR)

DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first.

Jacobio Pharmaceuticals Co., Ltd.

JAB-3068 will be administered orally in the morning following a fast of approximately 6 hours before on PK collection. Patients will continue to fast for approximately 2 hours after the administration of JAB-3068. On non-PK days patients will fast approximately 2 hours before JAB-3068 and continue to fast for approximately 2 hours afterwards.

Yuankai Shi, MD

Chunmei Bai, MD

Jian Fang, MD

Lin Shen, MD

Weiwei Shi, MD

This is a Phase 1/2a, open-label, multi-center study of JAB-3068 in Patients with advanced solid tumors.This study has two phases: dose escalation phase and dose expansion phase.

Dose escalation study phase is designed to determine the maximum tolerated dose (MTD) according to a 3+3 design and recommended phase II dose (RP2D) and to characterize the safety, tolerability, and pharmacokinetics (PK) profile of JAB-3068. Other dose regimens may be explored based on the analysis of emerging PK and safety data. at this study phase, JAB-3068 dministered orally once daily (QD) or twice daily (BID) or once every other day (QOD) in 28-day treatment cycles to adult patients with advanced solid tumors,

Dose expansion study phase is designed to evaluate the antitumor activity(ORR and DOR) of JAB-3068 in patients with NSCLC, ESCC and HNSCC.

A First-in-Human Study of JAB-3068 (SHP2 Inhibitor) in Adult Patients With Advanced Solid Tumors in China

A Phase 1/2a, Multi-Center, Dose Escalation/Dose Expansion, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-3068 in Adult Patients With Advanced Solid Tumors

Number of participants with dose limiting toxicities (DLTs) in the dose escalation phase. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first treatment cycle with JAB-3068.

ORR is defined as the proportion of participants with complete response or partial. the ORR of JAB-3068 in patients with ESCC, NSCLC and HNSCC will be evaluated separately in dose expansion

DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first. The DOR of JAB-3068 in patients with ESCC, NSCLC and HNSCC will be evaluated separately in dose expansion

ORR is defined as the proportion of participants with complete response or partial response (CR+PR) in dose escalation.

DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first in dose escalation.

BR790 will be administered orally, variable dose on Day 1 of each 21-day cycle, Anlotinib will be administered as PO fixed dose on Day1-14 of each 21-day cycle

BR790 will be administered orally, variable dose on Day 1 of each 21-day cycle， Anlotinib will be administered as PO fixed dose on Day1-14 of each 21-day cycle

BR790+anlotinib

Baohui Han, professor

Baohui Han

This is a Phase Ⅰ/Ⅱa, multi-center, open-label study, aiming to evaluate the safety, tolerability, pharmacokinetic (PK), and efficacy of BR790 in combination with anlotinib in adult participants with advanced NSCLC.

This study is a Phase Ⅰ/Ⅱa, multi-center, open-label study of BR790 in combination with anlotinib with a dose escalation part followed by a dose expansion part in adult subjects with advanced NSCLC. Participants will be treated until disease progression per RECIST v1.1, unacceptable toxicity, or other criteria for withdrawal are met, whichever occurs first.

BR790 in Combination With Anlotinib in Adult Subjects With Advanced Non-Small Cell Lung Cancer

A Multicenter, Open Phase Ⅰ/Ⅱa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BR790 in Combination With Anlotinib in Subjects With Advanced Non-small Cell Lung Cancer

To evaluate the MTD/RP2D of BR790 in combination with anlotinib (Part 1)

To evaluate the objective response rate (ORR) of BR790 in combination with anlotinib. ORR is defined as the proportion of subjects who achieve a Complete Response (CR) or Partial Response (PR) as assessed by RECIST v1.1 (Part 2)

PFS was defined as the time from randomization to documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or death due to any cause, whichever occurred first.

DOR is defined as the time from the first documented CR or PR per RECIST v1.1 to disease recurrence or disease progression (PD) whichever occurs first.

DCR is defined as the proportion of subjects who achieve a Complete Response (CR) 、Partial Response (PR) or Stable Disease (SD) as assessed by RECIST v1.1

OS is defined as the time from study treatment initiation to death from any cause or last day known to be alive.

Incidence, nature, and severity of treatment-emergent AEs and serious AEs, including incidence and severity of findings in laboratory values and vital signs for combination therapy

Area under the plasma concentration time curve of BR790/anlotinib

Highest observed plasma concentration of BR790/anlotinib

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.
RLY-1971 in Subjects With Advanced or Metastatic Solid Tumors	NCT04252339	Solid Tumor, Un...	RLY-1971	18 Years -	Hoffmann-La Roche
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.
RLY-1971 in Subjects With Advanced or Metastatic Solid Tumors	NCT04252339	Solid Tumor, Un...	RLY-1971	18 Years -	Hoffmann-La Roche
RLY-1971 in Subjects With Advanced or Metastatic Solid Tumors	NCT04252339	Solid Tumor, Un...	RLY-1971	18 Years -	Hoffmann-La Roche
A First in Human, Dose Escalation Study of JAB-3068 （SHP2 Inhibitor） in Adult Patients With Advanced Solid Tumors	NCT03518554	Non-small Cell ... Head and Neck C... Esophageal Canc... Other Metastati...	JAB-3068	18 Years -	Jacobio Pharmaceuticals Co., Ltd.
A First in Human, Dose Escalation Study of JAB-3068 （SHP2 Inhibitor） in Adult Patients With Advanced Solid Tumors	NCT03518554	Non-small Cell ... Head and Neck C... Esophageal Canc... Other Metastati...	JAB-3068	18 Years -	Jacobio Pharmaceuticals 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.
A First-in-Human Study of JAB-3068 (SHP2 Inhibitor) in Adult Patients With Advanced Solid Tumors in China	NCT03565003	Non-small Cell ... Head and Neck C... Esophageal Canc... Other Metastati...	JAB-3068	18 Years -	Jacobio Pharmaceuticals Co., Ltd.
A First-in-Human Study of JAB-3068 (SHP2 Inhibitor) in Adult Patients With Advanced Solid Tumors in China	NCT03565003	Non-small Cell ... Head and Neck C... Esophageal Canc... Other Metastati...	JAB-3068	18 Years -	Jacobio Pharmaceuticals Co., Ltd.
BR790 in Combination With Anlotinib in Adult Subjects With Advanced Non-Small Cell Lung Cancer	NCT05715398	Non-Small Cell ...	BR790+anlotinib	18 Years - 75 Years	Shanghai Gopherwood Biotech Co., Ltd.

Spots Global Cancer Trial Database for ptpn11

Every month we try and update this database with for ptpn11 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 ptpn11

Every month we try and update this database with for ptpn11 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 ptpn11 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.