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AzTrials

Colorectal CancerPhase 1NCT05954871

Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-1971 in Combination With Either Osimertinib in Participants With Unresectable, Locally Advanced, or Metastatic Non-Small Cell Lung Cancer, or With Cetuximab in Participants With Metastatic Colorectal Cancer

A Phase 1 study testing GDC-1971, Osimertinib and Cetuximab in people with Colorectal Cancer and Non-Small Cell Lung Cancer, run by Genentech, Inc. at 6 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The main purpose of the study is to evaluate the safety of GDC-1971 in combination with either osimertinib or cetuximab. The study consists of a dose-finding stage followed by an expansion stage. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer, Non-Small Cell Lung Cancer
What is being tested?
GDC-1971, Osimertinib and Cetuximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
6 sitesin 3 countries
Study dates
8 Jan 2024to 16 Sep 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Evaluable or measurable disease per RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy of ≥12 weeks
  • Adequate hematologic and organ function within 14 days prior to initiation of study Inclusion Criteria for Non-Small Cell Lung Cancer Cohorts
  • Histologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of the lung that has progressed on/after prior treatment with third-generation epidermal growth factor receptor (EGFR) inhibitor (e.g., osimertinib)
  • Positive for an EGFR exon 19 deletion or exon 21 L858R mutation
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  • Negative for acquired on-target EGFR alterations Inclusion Criteria for Colorectal Cancer Cohorts
  • Histologically confirmed metastatic adenocarcinoma of the colon or rectum that has progressed on/after prior treatment with an EGFR inhibitor (e.g., cetuximab or panitumumab)
  • Negative for kirsten rat sarcoma viral oncogene homolog (KRAS) alterations
  • Negative for neuroblastoma RAS viral oncogene homolog (NRAS) alterations
  • Negative for proto-oncogene B-Raf (BRAF) V600E alterations
  • In lieu of a fresh pre-treatment biopsy, a recently obtained biopsy performed after completion of osimertinib therapy will be acceptable

Who cannot join

  • Treatment with chemotherapy, immunotherapy, biologic therapy, or an investigational agent as anti-cancer therapy within 3 weeks or 5 drug elimination half-lives, whichever is shorter, prior to initiation of study treatment
  • Treatment with endocrine therapy within 2 weeks prior to initiation of study drug, except for hormonal therapy with gonadotropin-releasing hormone agonists or antagonists for endocrine-sensitive cancers
  • Significant traumatic injury or major surgical procedure within 4 weeks prior to Cycle 1, Day 1
  • Positive hepatitis C virus (HCV) antibody test at screening
  • Positive hepatitis B surface antigen (HBsAg) test at screening
  • Known HIV infection
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  • Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
  • Uncontrolled hypercalcemia
  • Substance abuse, as determined by the investigator, within 12 months prior to screening
  • Poor peripheral venous access
  • Inability or unwillingness to swallow pills
  • Malabsorption syndrome or other condition that would interfere with enteral absorption Chronic diarrhea, short bowel syndrome, or significant upper GI surgery including gastric resection, a history of inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), or any active bowel inflammation (including diverticulitis)
  • Serious infection within 4 weeks prior to screening
  • History of malignancy within 3 years prior to screening
  • Known and untreated, or active central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control)
  • Leptomeningeal disease or carcinomatous meningitis
  • History or presence of an abnormal electrocardiogram (ECG) that is deemed clinically significant by the investigator (e.g., complete left bundle branch block, second- or third-degree atrioventricular heart block) or evidence of prior myocardial infarction
  • Left ventricular ejection fraction (LVEF) less than the institutional lower limit of normal (LLN) or <50%
  • History or evidence of ophthalmic disease
  • History of or active clinically significant cardiovascular dysfunction
  • History of pulmonary firbrosis, organizing pneumonia, or pneumonitis
  • Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

6 sites in 3 countries.

6 sites in 3 countries

United States2 sites

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

  • START South Texas Accelerated Research Therapeutics-San Antonio

    San Antonio, Texas, 78229

Other trials in United States

Australia2 sites

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Border Medical Oncology

    Wodonga, New South Wales, 3690

Other trials in Australia

South Korea2 sites

  • Seoul National University Hospital

    Seoul, 03080

  • Asan Medical Center

    Seoul, 05505

Other trials in South Korea

About this study

Official title: A Phase Ib Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-1971 in Combination With Either Osimertinib in Patients With Unresectable, Locally Advanced, or Metastatic Non-Small Cell Lung Cancer, or With Cetuximab in Patients With Metastatic Colorectal Cancer

The main purpose of the study is to evaluate the safety of GDC-1971 in combination with either osimertinib or cetuximab. The study consists of a dose-finding stage followed by an expansion stage.

Being tested
GDC-1971, Osimertinib, Cetuximab
Medical subject headings
Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GDC-1971Drug

    Also called RO7517834, RLY-1971

    GDC-1971 capsules or tablets will be administered as specified in each treatment arm.

  • OsimertinibDrug

    Osimertinib tablets will be administered as specified in each treatment arm.

  • CetuximabDrug

    Cetuximab, solution for infusion will be administered as specified in each treatment arm.

Study groups in NCT05954871
Study groupRoleWhat they receive
Dose-Finding Stage: Non-Small Cell Lung Cancer (NSCLC)ExperimentalParticipants with unresectable, locally advanced or metastatic NSCLC will receive GDC-1971 at an assigned dose, orally, once daily (QD), on Days 1 to 28 of each 28-day cycle in combination with osimertinib, 80 milligrams (mg), orally, QD, on Days 1 to 28 of each cycle until disease progression or unacceptable toxicity.
Receives: Drug: GDC-1971; Drug: Osimertinib
Dose-Finding Stage: Colorectal Cancer (CRC)ExperimentalParticipants with metastatic CRC will receive GDC-1971, at an assigned dose, orally, QD, on Days 1 to 28 days of each 28-day cycle in combination with cetuximab, 500 milligrams per square meter (mg/m^2), given by IV infusion on Days 1 and 15 of each cycle, until disease progression or unacceptable toxicity.
Receives: Drug: GDC-1971; Drug: Cetuximab
Dose Expansion Stage: NSCLCExperimentalParticipants with unresectable, locally advanced or metastatic NSCLC will receive GDC-1971 at a dose determined in the dose finding stage, orally, QD, on Days 1 to 28 of each 28-day cycle in combination with osimertinib, 80 mg, orally, QD, on Days 1 to 28 of each cycle until disease progression or unacceptable toxicity.
Receives: Drug: GDC-1971; Drug: Osimertinib
Dose Expansion Stage: CRCExperimentalParticipants with metastatic CRC will receive GDC-1971 at a dose determined in the dose finding stage, orally, QD, on Days 1 to 28 of each 28-day cycle in combination with cetuximab, 500 mg/m^2, given by IV infusion on Days 1 and 15 of each cycle until disease progression or unacceptable toxicity.
Receives: Drug: GDC-1971; Drug: Cetuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants with Adverse Events (AEs) Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

    Measured: Up to approximately 41 months

  2. Number of Participants with Dose-Limiting Toxicities (DLTs)

    Measured: Day 1 through Day 28 of Cycle 1 (1cycle= 28 days)

Secondary outcomes (5)

  1. Plasma Concentration of GDC-1971

    Measured: Up to approximately 41 months

  2. Plasma Concentration of Osimertinib

    Measured: Up to approximately 41 months

  3. Objective Response Rate (ORR) as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).

    Measured: Up to approximately 41 months

  4. Duration of Response (DOR) as Determined by Investigator According to RECIST v1.1

    Measured: Up to approximately 41 months

  5. Progression-Free Survival (PFS) After Enrollment as Determined by Investigator According to RECIST v1.1

    Measured: Up to approximately 41 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2023
  2. Study start8 Jan 2024
  3. Primary completion16 Sep 2025
  4. Study completion16 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05954871
Sponsor's protocol ID
GO44272
Other IDs
2022-502530-10-00
Status last verified
Nov 2025
First submitted
12 Jul 2023
Last updated
13 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GDC-1971, Osimertinib and Cetuximab in people with Colorectal Cancer and Non-Small Cell Lung Cancer, run by Genentech, Inc. at 6 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, Australia, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants with Adverse Events (AEs) Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 (time frame: Up to approximately 41 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05954871.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2025.

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