Experimental cancer combo trial halted early
NCT ID NCT06337630
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tested two experimental drugs, tuvusertib and PLX038, in 10 adults with advanced solid tumors that had not responded to standard treatments. The goal was to find a safe dose and see if the combination could shrink tumors. However, the study was terminated early, so results are limited.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tuvusertib and PLX038
- What this could lead to
- If it works, this combination could point toward a new treatment option for advanced solid tumors that have stopped responding to standard chemotherapy.
- What could go wrong
- This was a very early, small phase 1 trial that was terminated before completion. It is unclear if the combination is safe or effective, and it may never reach patients.
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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10 people
The number who actually took part.
- Started
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Jan 2025
- Finished
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Nov 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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.
Inclusion Criteria: * Willing and able to comply with the protocol and provide written informed consent prior to study-specific screening procedures. * Age ≥ 18 years. * Locally advanced or metastatic solid cancer that is not amenable to curative treatment. * Measurable disease (per RECIST version 1.1). * Received a minimum of one and a maximum of six prior cytotoxic chemotherapy regimens for locally advanced or metastatic cancer. * Resolution of chemotherapy and radiation therapy related toxicities to NCI-CTCAE version 5.0 Grade 1 or lower severity, except for stable sensory neuropathy (≤ Grade 2), alopecia (any grade), presence of clinically managed chronic autoimmune AEs from prior immune therapy. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate organ function (obtained within 14 days prior to treatment start) as evidenced by: i. Absolute neutrophil count (ANC) ≥ 1.5 X 109/L; ii. Hemoglobin (Hgb) ≥ 9 g/dL; iii. Platelet count ≥ 100 X 109/L; iv. Bilirubin ≤ 1.5 X upper limit of normal (ULN), except for patients with a documented history of Gilbert's disease (≤ 2 X ULN); v. Alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ 2.5 X ULN (for patients with liver metastases ≤ 5 X ULN); vi. Alkaline phosphatase (ALP) ≤ 3 X ULN (for patients with liver metastases, ≤ 5 X ULN); vii. Serum creatinine ≤ 1.5 mg/dL (133 μmol/L) or calculated creatinine clearance ≥ 50 mL/min (using Cockcroft-Gault formula); viii. Women of childbearing potential (WCBP): negative serum pregnancy test. * Full blood count parameters described above must meet the thresholds with no transfusion or growth factor support in the past 14 days. * Patients covered by social security or health insurance in compliance with the national legislation relating to biomedical research. * The willingness to remain on contraception of childbearing potential for the duration of study treatment plus 7 months (women) or 4 months (men). Exclusion Criteria: * Patients who have had a last dose of IV chemotherapy within 21 days, last dose of oral cytotoxic chemotherapy, radiotherapy, biological therapy, or investigational therapy within 14 days prior to treatment start. * Patients who have had any major surgery within 28 days prior to inclusion. * Patients with chronic inflammatory bowel disease and/or bowel obstruction. * Concomitant use of other agents for the treatment of cancer (except for LHRH agonist/antagonist) or any investigational agent(s). * Brain metastases, unless local therapy was completed and use of corticosteroids for this indication discontinued for at least 3 weeks prior to inclusion. Signs or symptoms of brain metastases must be stable for at least 28 days prior to inclusion. No known progression of brain metastases (by imaging as assessed by RECIST version 1.1) can have occurred. Patients with leptomeningeal disease or meningeal carcinomatosis are excluded. * Women who are either pregnant, lactating, planning to get pregnant. * Patients receiving pharmacotherapy for hepatitis B or C, tuberculosis, or HIV. * Patients with known liver disease diagnosed with Child-Pugh A or higher cirrhosis. * Other current or previous stage III or IV malignancy diagnosed within 5 years of study entry. * Severe/uncontrolled intercurrent illness within the previous 28 days prior to inclusion. * Uncontrolled or poorly controlled arterial hypertension, symptomatic congestive heart failure (New York Heart Association Classification ≥ Class III), uncontrolled cardiac arrhythmia, calculated QTc average using the QTcF \> 480 msec; unstable angina pectoris, myocardial infarction or a coronary revascularization procedure, cerebral vascular accident, transient ischemic attack, or any other significant vascular disease within 180 days of study intervention start. * Patients with ongoing active infection (requiring systemic treatment) and treatment with live or live attenuated vaccine within 30 days of dosing. * Any other significant medical, psychological, social or geographic conditions that in the opinion of the Investigator would impair study participation or cooperation. * Patients deprived of their liberty or under guardianship. Dose expansion additional inclusion criteria Breast cancer * Triple-negative breast cancer (both ER and PR \<10%, HER2-negative or HER2-low, locally assessed). * Prior therapy (administered in the neoadjuvant, adjuvant and/or metastatic setting) with an anthracycline, taxane and sacituzumab govitecan (unless not medically appropriate or contraindicated for the patient). * Patients with known gBRCA mutations must have received a PARP inhibitor in the metastatic setting. * Patients whose cancer has a CPS score ≥10 must have received prior pembrolizumab unless (i) contra-indicated (ii) CPS score or pembrolizumab not available at time of first line treatment start. ATM-mutated solid cancers ● Inactivating mutation of ATM (presence of truncating mutation or R337/R3008 missense mutation of ATM mono and/or biallelic, assessed by next-generation sequencing in a certified French genomics platform).
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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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Institut Curie
Paris, 75005, France
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Institut Curie
Saint-Cloud, 92210, France
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