A Study of GFH925 in Patients With Advanced Solid Tumors With KRAS G12C Mutations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

334 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-13

Study Completion Date

2024-12-20

Brief Summary

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Phase Ia:

To evaluate the safety/tolerability of GFH925 in subjects with KRAS G12C-mutated advanced solid tumors; To estimate the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of GFH925.

Phase Ib:

To evaluate the efficacy of GFH925 in subjects with KRAS G12C mutant advanced colorectal cancer or other tumors.

Phase II:

To evaluate the efficacy of GFH925 in subjects with KRAS G12C mutant advanced non-small cell lung cancer (NSCLC).

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Detailed Description

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Conditions

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KRAS G12C

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GFH925

Phase Ia Dose Escalation Subjects with advanced NSCLC and gastrointestinal tumors will be enrolled in dose escalation cohorts based on Bayesian optimal interval (BOIN) design.

Phase Ia Dose Expansion Upon completing the dose exploration part of the study and depending on data obtained, dose expansion may proceed with responsive groups consisting of subjects with KRAS G12C mutant advanced NSCLC. Dose expansion may be done concurrently.

Phase Ib Subjects with KRAS G12C mutant advanced colorectal cancer or other tumors will be enrolled and treated at the monotherapy RP2D to evaluate the efficacy.

Phase 2 Subjects with KRAS G12C mutant advanced NSCLC will be enrolled and treated at the monotherapy RP2D to evaluate the safety and efficacy.

Group Type EXPERIMENTAL

GFH925

Intervention Type DRUG

Administered as an oral tablet formulation

Interventions

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GFH925

Administered as an oral tablet formulation

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Volunteer to participate in the study and sign the informed consent form.
2. Aged 18 years or older at the time of signing the informed consent form.
3. Subjects must have one measurable lesion (per RECIST 1.1).
4. Subjects with toxic reaction caused by prior anticancer therapy need to have recovered to baseline level (except residual alopecia) or ≤ Grade 1 (neurotoxicity ≤ Grade 2 acceptable).
5. Eastern Cooperative Oncology Group (ECOG) performance status score (PS) 0 \~ 1.
6. Expected survival ≥ 12 weeks.
7. Female subjects or male subjects of childbearing potential must take effective contraceptive measures from the time of signing the informed consent form to 30 days after the last dose of GFH925, or to 60 days after the last dose of cetuximab. Female subjects of childbearing potential should have a negative blood pregnancy test within 7 days (inclusive) prior to initiation of study treatment.
8. The investigators deem the subject able to communicate well, attend regular follow-up visits, and complete the study according to the protocol.

Exclusion Criteria

1. Significant cardiovascular system disease.
2. Subjects with unstable brain metastases diagnosed by investigators.
3. Significant gastrointestinal diseases, such as intractable hiccup, nausea, vomiting, severe gastrointestinal ulcers, cirrhosis, active gastrointestinal bleeding, or other diseases that affect swallowing tablets or significantly affect oral drug absorption; subjects with severe portal hypertension caused by the presence of Budd-Chiari syndrome or portal emboli in subjects with liver cancer also need to be excluded.
4. Presence of serious acute or chronic infections.
5. Pregnant or lactating women.
6. Known allergy to the study drug or any component of its formulation.
7. Other conditions that the investigators consider inappropriate for participation in this study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No