New drug cocktail aims to tackle Hard-to-Treat cancers
NCT ID NCT06499350
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This early-phase trial is testing a combination of two drugs—FC084CSA and tislelizumab—in people with advanced solid tumors that have stopped responding to standard treatments. The study aims to find the safest dose and see if the combo can control tumor growth. Only 33 participants will be enrolled, so results are very preliminary.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- FC084CSA (AXL inhibitor) combined with tislelizumab (PD-1 inhibitor)
- What this could lead to
- If successful, this could point toward a new treatment option for advanced solid tumors that have not responded to standard therapies.
- What could go wrong
- This is a very early, small trial (33 people) focused on safety and dosing. The combination may not shrink tumors or could cause significant 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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 33 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- 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 to 75 years
- 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: 1. Aged 18 to 75 years old male and female. 2. Phase Ib: Patients with histologically or cytologically diagnosed solid tumors who have failed standard therapy; Phase IIa: Patients with histologically or cytologically confirmed stage IIIB/IIIC and stage IV NSCLC which surgery or radiotherapy cannot be performed. 3. No known sensitizing mutations or other actionable oncogenes with approved therapies if available. 4. Prior PD-1/PD-L1 inhibitor combined with platinum-containing therapy failed; 5. According to RECIST 1.1, there is at least one measurable lesion. 6. ECOG performance status 0-1. 7. Major organs are functioning well. Exclusion Criteria: 1. Not recovered from the adverse reactions caused by previous anti-tumor treatments (≥CTCAE grade 1). 2. Received anti-tumor therapy within 4 weeks before enrollment. 3. Participated in other clinical trials within 4 weeks before enrollment and used clinical investigational drugs during this period. 4. Have undergone surgery within 4 weeks before enrollment, and the investigator believes that the patient's state has not recovered to the point where the study can be started. 5. Patients with ascites (ascites), pleural effusion (pleural effusion) or pericardial effusion that cannot be controlled by drainage or other methods. 6. Central nervous system metastases with clinical symptoms. 7. With any situations that the researcher considers inappropriate to participate in this research.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shanghai East Hospital
RECRUITINGShanghai, Shanghai Municipality, 200120, China
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- New injectable drug tested against Hard-to-Treat solid tumors