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

JRCT ID: jRCT2031220195

Registered date:07/07/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: advanced solid tumor
• Date of first enrollment: 06/09/2022
• Target sample size: 48
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

Primary Outcome

Safety, Phamacokinetics
AE
Dose limiting toxicity
Vital signs, clinical laboratory tests, and ECG
Pharmacokinetics

Secondary Outcome

Efficacy
Efficacy based on RECIST v1.1

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Yanagitani Noriko