A PHASE Ia/Ib DOSE-ESCALATION AND DOSE EXPANSION STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, AND ACTIVITY OF GDC-6036 AS A SINGLE AGENT AND IN COMBINATION WITH OTHER ANTI-CANCER THERAPIES IN PATIENTS WITH ADVANCED OR METASTATIC SOLID TUMORS WITH A KRAS G12C MUTATIO

Recruiting

Conditions: Locally Advanced or Metastatic Solid Tumors
locally advanced or tumors that metastasized
10017990
10027655
10029107

Registration Number: NL-OMON56305

Lead Sponsor: Genentech Inc. (een lid van de Roche groep)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

• Histologically documented advanced or metastatic solid tumor with KRAS G12C
mutation • Age > 18 years at time of signing Informed Consent Form • Women
of childbearing potential must agree to remain abstinent or use contraception,
and agree to refrain from donating eggs during the treatment period and after
the final dose of study as specified in the protocol • Men who are not
surgically sterile must agree to remain abstinent or use contraception, and
agreement to refrain from donating sperm during the treatment period and after
the final dose of study treatment as specified in the protocol

Exclusion Criteria

• Malabsorption or other condition that interferes with enteral absorption
• Active brain metastases
• Clinically significant cardiovascular dysfunction or liver disease

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Incidence and severity of adverse events, with severity determined according<br /><br>to National Cancer Institute Common Terminology Criteria for Adverse Events,<br /><br>Version 5.0 (NCI CTCAE v5.0)<br /><br>• Incidence and nature of dose-limiting toxicities (DLTs)<br /><br>• Change from baseline in targeted vital signs<br /><br>• Change from baseline in targeted clinical laboratory test results<br /><br>• Change from baseline in targeted ECG parameters</p><br>

Secondary Outcome Measures