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A Study to Evaluate the Safety and Activity of GDC-7035 With Anti-Cancer Therapies in Participants With KRAS G12D-Mutated Unresectable Advanced or Metastatic Colorectal Cancer or Pancreatic Ductal Adenocarcinoma

ConditionsColorectal NeoplasmsPancreatic Ductal Adenocarcinoma
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGenentech, Inc.

About this trial

The primary purpose of this study is to evaluate the safety of GDC-7035 as a single agent and in combination with other anti-cancer therapies in participants with KRAS G12D-mutated metastatic colorectal cancer (CRC) or pancreatic ductal adenocarcinoma (PDAC). The study consists of a safety run-in period followed by a randomized/expansion period.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed presence of the Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D mutation as documented through central laboratory testing or prior local laboratory testing

Agreement to adhere to the contraception requirements described in the protocol for participants of childbearing potential and participants who produce sperm

Disqualifiers

Malabsorption syndrome or other conditions that would interfere with enteral absorption

Known and untreated, or active central nervous system (CNS) metastases

Known clinically significant liver disease

History of or active clinically significant cardiovascular dysfunction

Trial design

Design model

Sequential

Treatments tested in this trial

  • GDC-7035

    Drug

    Participants will receive GDC-7035 as per the schedule specified in the protocol.

  • Panitumumab

    Biological/Vaccine

    Participants will receive panitumumab in accordance with the local prescribing information.

  • mFOLFOX6

    Drug

    Participants will receive mFOLFOX6 in accordance with the local prescribing information.

  • FOLFIRI

    Drug

    Participants will receive FOLFIRI in accordance with the local prescribing information.

  • mFOLFIRINOX

    Drug

    Participants will receive mFOLFIRINOX in accordance with the local prescribing information.

  • Gem-nabP

    Drug

    Participants will receive Gem-nabP in accordance with the local prescribing information.

Treatment groups

388 Participants
are divided into 4 treatment groups
Group A: Group A: GDC-7035 + mFOLFOX6 + PanitumumabExperimental treatment 3 interventions
Group B: Group B: GDC-7035 + FOLFIRI + PanitumumabExperimental treatment 3 interventions
Group C: Group C: GDC-7035 + mFOLFIRINOX or GDC-7035 MonotherapyExperimental treatment 2 interventions
Group D: Group D: GDC-7035 + Gem-nabP or GDC-7035 MonotherapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of Participants With Adverse Events (AEs)

Time frame
Up to approximately 30 months
2

Number of Participants With Key Treatment-Emergent Adverse Events (TEAEs)

Time frame
Up to Day 28

Secondary outcomes

1

Objective Response Rate (ORR)

Time frame
Up to approximately 30 months
2

Duration of Response (DOR)

Time frame
Up to approximately 30 months
3

Progression-free Survival (PFS) After Randomization

Time frame
Up to approximately 30 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Genentech, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: