Phase I Study of GDC-6036 and GDC-1971 in Patients with Advanced Solid Tumors

Phase I Study of GDC-6036 (RO7435846) and GDC-1971 (RO7517834) as Single Agent, in Combination with Both Agents, and in Combination with Other Anti-Cancer Agents in Patients with Advanced Solid Tumor

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031220195

Enrollment

Registered

2022-07-07

Start date

2022-09-05

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced solid tumor

Interventions

GDC-6036: GDC-6036 will be administered at specified dose, orally, once daily. GDC-1971: GDC-1971 will be administered at specified dose, orally, once daily.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histologically or cytologically documented solid tumor Advanced or recurrent for which standard therapy is ineffective or inappropriate, or for which no standard therapy exists ECOG PS of Grade 0 or 1 (GDC-6036 cohort and GDC-6036 + GDC-1971 cohort) KRAS G12C alteration has been identified

Exclusion criteria

Exclusion criteria: Patients who have difficultly taking oral medications Uncontrolled hypertension or hypercalcaemia (GDC-6036 cohort and GDC-6036 + GDC-1971 cohort) Patients who have discontinued a prior KRAS G12C inhibitor because of toxicity assessed as related to the treatment (GDC-1971 cohort and GDC-6036 + GDC-1971 cohort) Patients who have discontinued a prior SHP2 inhibitor because of toxicity assessed as related to the treatment

Design outcomes

Primary

Measure	Time frame
Safety, Phamacokinetics AE Dose limiting toxicity Vital signs, clinical laboratory tests, and ECG Pharmacokinetics	—

Secondary

Measure	Time frame
Efficacy Efficacy based on RECIST v1.1	—

Contacts

Public ContactClinical trials information

Chugai Pharmaceutical Co., Ltd.

clinical-trials@chugai-pharm.co.jp+81-120-189-706

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026