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RecruitingLast updated: 9 January 2024

This phase I study is evaluating how safe and effective a new oral drug (GDC-1971) is when given in combination with immunotherapy (atezolizumab) in people with locally advanced or metastatic solid cancersA Phase Ib, Open-Label Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-1971 in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

Clinical summary

Summary

This study will have two stages: dose finding stage and expansion stage. The Dose Finding stage will enrol people with advanced solid cancers, who will receive GDC-1971 (orally) once daily on Days 1-21 of each cycle, along with atezolizumab (1200mg, administered by intravenous infusion) once every 3 weeks. The Expansion Stage will enrol cohorts of participants with non-small cell lung cancer PD L-1high), non-small lung cancer PD L-1low, head and neck squamous cell carcinoma PDL-1 positive, BRAF wild type melanoma, and any locally advanced or metastatic solid cancers. In this stage, participants will receive GDC-1971 (orally) daily on Days 1-21 of each cycle, plus atezolizumab (1200mg, intravenously) on Day 1 of each cycle. Omeprazole will be administered orally in the acid-reducing agent assessment.

Conditions

This trial is treating patients with advanced solid cancers, plus additional cohorts of people with non-small cell lung cancer, head and neck squamous cell carcinoma, and BRAF wild type melanoma.

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Genentech

Scientific Title

A Phase Ib, Open-Label Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-1971 in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

Eligibility

Inclusion

  • Has Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1
  • Has Life expectancy >= 12 weeks
  • Adequate organ function
  • Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).

Inclusion Criteria for Dose-Finding Stage:

  • Histologically confirmed locally advanced or metastatic solid tumor that has progressed after at least one available standard therapy or for which approved standard therapy has proven to be ineffective or intolerable

Inclusion Criteria for Expansion Stage: NSCLC Cohort

  • Histologically confirmed locally advanced or metastatic NSCLC
  • Absence of epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK)
  • PD- L1 positive
  • No prior systemic therapy for locally advanced or metastatic NSCLC

Inclusion Criteria for Expansion Stage: HNSCC Cohort

  • Histologically confirmed recurrent, or metastatic HNSCC
  • PD-L1 positive
  • No prior systemic therapy for recurrent or metastatic HNSCC

Inclusion Criteria for Expansion Stage: BRAF WT melanoma Cohort

  • Histologically confirmed locally advanced or metastatic or unresectable locally advanced cutaneous BRAF WT melanoma or melanomas of unknown primary that are non-mucosal and non -uveal that has progressed on or after treatment that included anti PD1 or anti PD-L1 therapy

Inclusion Criteria for Expansion Stage: Other Advanced or Metastatic Solid Tumors Cohort

  • Histologically confirmed locally advanced or metastatic solid tumor that has progressed after at least one available standard therapy or for which approved standard therapy has proven to be ineffective or intolerable, standard therapy is considered inappropriate, or an investigational agent is a recognized standard of care

Exclusion

  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
  • Has leptomeningeal disease or carcinomatous meningitis
  • Has uncontrolled hypertension
  • Has left ventricular ejection fraction < institutional lower limit of normal or < 50%
  • Has clinically significant history of liver disease including viral or other hepatitis, current alcohol abuse, or cirrhosis
  • Has an active or history of autoimmune disease or immune deficiency including myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or multiple sclerosis. Participants with a history of autoimmune- related hypothyroidism on thyroid replacement hormone or with controlled Type I diabetes mellitus on a stable dose of an insulin regimen are eligible for this study

Inclusion

  • You are able to swallow medication by mouth.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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