Clinical trial NCT06619587: A Study to Evaluate Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination in Patients With Advanced Solid Tumors
Official title: A Phase I/II Dose-Escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors With a KRAS G12D Mutation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Solid Tumor
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2024-10-01
Enrollment: 410
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a first-in-human Phase I/II, open-label, multicenter, dose-escalation and expansion study designed to evaluate the safety, pharmacokinetics, and preliminary activity of GDC-7035 as a single agent and in combination with other anti-cancer therapies in participants with advanced or metastatic solid tumors that harbor the KRAS G12D mutation.


Eligibility criteria: Inclusion Criteria:

* Histologically documented advanced or metastatic solid tumor with KRAS G12D mutation
* Agreement to adhere to the contraception requirements described in the protocol for participants of childbearing potential and participants who produce sperm

Exclusion criteria:

* Malabsorption or other condition that would interfere with enteral absorption
* Active brain metastases
* Clinically significant cardiovascular dysfunction or liver disease

Primary outcomes:
measure: Percentage of Participants with Adverse Events, with Severity Determined According to the CTCAE v5.0 Grading Scale
timeFrame: 4 Years
measure: Percentage of Participants with Dose Limiting Toxicity
timeFrame: 4 Years
Secondary outcomes:
measure: Plasma Concentrations of GDC-7035 at Specified Timepoints
timeFrame: 4 Years
measure: Blood Concentrations of GDC-7035 at Specified Timepoints
timeFrame: 4 Years
measure: Plasma Concentrations at Specified Timepoints of GDC-7035 Administered in the Fasted State or with a Standardized High-Fat Meal
timeFrame: 4 Years
measure: Blood Concentrations at Specified Timepoints of GDC-7035 Administered in the Fasted State or with a Standardized High-Fat Meal
timeFrame: 4 Years
measure: Objective Response Rate Among Participants
timeFrame: 4 Years
measure: Duration of Response Among Participants
timeFrame: 4 Years
measure: Median Progression Free Survival Time Among Participants
timeFrame: 4 Years
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital Sydney
state: New South Wales
city: Parkville
country: Australia
facility: Peter Maccallum Cancer Centre
state: Victoria
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency
state: British Columbia
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: Sir Mortimer B Davis Jewish General Hospital
state: Quebec
city: Tel Aviv-Yafo
country: Israel
facility: Tel Aviv Sourasky Medical Center PPDS
city: Barcelona
country: Spain
facility: Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON
city: Madrid
country: Spain
facility: START Madrid_Hospital Universitario HM Sanchinarro_CIOCC
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: