New pill and immunotherapy combo tested for Hard-to-Treat cancers
NCT ID NCT06082960
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This early-phase study tests a new oral drug called GS-9911, alone or with an intravenous immunotherapy (zimberelimab), in 45 adults with advanced solid tumors who have run out of standard options. The main goals are to check safety, find the best dose, and see how the body handles the drug.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GS-9911 (oral tablet) and zimberelimab (intravenous infusion)
- What this could lead to
- If successful, this could point toward a new treatment option for advanced solid tumors that have stopped responding to other therapies.
- What could go wrong
- This is an early Phase 1 trial with only 45 participants, so it is primarily testing safety and dosing. The drug may not shrink tumors or may cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2023
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: * Parts A, C, and D: * Participants with histologically or cytologically confirmed advanced solid tumors who have received, been intolerant to, or are ineligible for all treatments known to confer clinical benefit * Part B: * Participants whose cancer previously derived clinical benefit from immune checkpoint inhibitors, or who have advanced solid tumor types for which immune checkpoint inhibitors are considered the standard of care and who have received, been intolerant to, or are ineligible for all treatments known to confer clinical benefit * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Evaluable (Part A) or measurable (Parts B, C, and D) disease as per Response Criteria Evaluation in Solid Tumors (RECIST) v1.1 criteria * Adequate organ functions * Tissue requirement: * Parts A-D: must be willing to provide baseline tumor tissue prior to enrollment * Part A backfill cohorts: a biopsy should be obtained prior to treatment and on treatment, if safely feasible * Participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified methods of contraception Exclusion Criteria: * Positive serum pregnancy test or lactating female * History of intolerance, hypersensitivity, or treatment discontinuation due to life- threatening immune-related adverse events on prior immunotherapy * Receipt of the therapies listed below within the specified timeframe prior to planned Cycle 1 Day 1 including: major surgery (\< 4 weeks), immunotherapy or biologic therapy (\< 28 days), chemotherapy (\< 21 days), targeted small molecule therapy (\<14 days or 5 half-lives, whichever is sooner), hormonal or other adjunctive therapy (\< 14 days), radiation therapy (\< 21 days), live vaccine (\< 28 days) * Any prior allogeneic tissue/solid organ transplantation, including allogeneic stem cell transplantation * Diagnosis of immunodeficiency, or requires systemic corticosteroids (\> 10 mg of prednisone daily, or equivalent) * History of autoimmune disease or active autoimmune disease that has required systemic treatment within 2 years prior to the start of study drug * History of pneumonitis requiring treatment with corticosteroids, interstitial lung disease, drug-induced pneumonitis, or severe radiation pneumonitis (excluding localized radiation pneumonitis) * Active second malignancy. Note: individuals with a history of malignancy that have been completed treated, with no evidence of active cancer for 2 years prior to enrollment, or individuals with surgically cured tumors with low risk of recurrence are allowed to enroll. * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Symptomatic cardiovascular disease * Active serious infection requiring ongoing treatment * Active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV. * Symptomatic ascites or pleural effusion Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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NEXT Oncology
San Antonio, Texas, 78229, United States
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Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000, Australia
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SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
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Smilow Cancer Hospital Phase 1 Unit
New Haven, Connecticut, 06520, United States
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South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, 78229, United States
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University Health Network, Princess Margaret Cancer Centre
Toronto, M5G, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First-in-Human trial asks whether HG381 is safe and tolerable in advanced solid tumors
- Custom-Built immune cells take aim at a notorious cancer mutation
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Oral drug RVU120 put to the test against advanced solid tumors