New Antibody-Drug combo targets Hard-to-Treat digestive cancers
NCT ID NCT05628857
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tested a drug called RC108 in 29 people with advanced digestive system cancers that have a protein called c-Met. RC108 is an antibody-drug combination given through a vein. The study looked at how well the drug shrinks tumors and what side effects occur. Results are not yet available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- RC108 (an antibody-drug combination given by IV)
- What this could lead to
- If successful, RC108 could offer a new treatment option for people with advanced digestive cancers that have a specific marker (c-Met).
- What could go wrong
- This is a small, early-phase trial with only 29 participants, so results may not apply to everyone. The drug may cause side effects or not work as hoped.
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
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
29 people
The number who actually took part.
- Started
-
Nov 2022
- Finished
-
Dec 2025
- Lead sponsor
-
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
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
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. Voluntary agreement to provide written informed consent. 2. Male or female, aged between 18 to 75 years. 3. Predicted survival for ≥ 12 weeks. Diagnosed with histologically or cytologically confirmed locally advanced or metastatic Digestive System Malignant Tumor. 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 5. All female subjects will be considered to be of child-bearing potential unless they are postmenopausal, or have been sterilized surgically. Female subjects of child-bearing potential must agree to use two forms of highly effective contraception. Male subjects and their female partner who are of child-bearing potential must agree to use two forms of highly effective contraception. 6. Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol. Adequate organ function, evidenced by the following laboratory result Participant has adequate bone marrow, renal, and hepatic function. 7. bone marrow function: Hemoglobin ≥ 9g/dL; Absolute neutrophil count ≥ 1.5×10\^9 /L Platelets ≥ 100×10\^9 /L. 8. hepatic function: Total bilirubin ≤ 1.5× ULN; AST and ALT ≤ 2.5×ULN and ≤ 5 x ULN with hepatic metastasis 9. renal, and hepatic function: Serum creatinine ≤1.5×ULN. 10. Cardiac ejection fraction ≥ 50%. Median QTc \< 450 ms. 11. c-Met positive as confirmed by the central laboratory. 12. Measurable lesion according to RECIST 1.1. Exclusion Criteria: 1. Known hypersensitivity to the components of RC108-ADC. 2. Toxicity of previous anti-tumor treatment not recovered to CTCAE (v5.0) Grade 0-1 (with exception of Grade 2 alopecia). 3. Uncontrolled pericardial effusion or cardiac tamponade, or pleural or abdominal effusion with clinical symptoms. 4. History of receiving any anti-cancer drug/biologic treatment within 4 weeks prior to trial treatment. 5. History of major surgery within 4 weeks of planned start of trial treatment. 6. Has received a live virus vaccine within 4 weeks of planned start of trial treatment. 7. Currently known active infection with HIV or tuberculosis. 8. Diagnosed with HBsAg, HBcAb positive and HBV DNA copy positive, or HCVAb positive. 9. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. 10. History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers with a similar curative outcome as those mentioned above. 11. Known central nervous system metastases. 12. Uncontrolled hypertension, diabetes, pulmonary fibrosis, acute lung disease, Interstitial lung disease, or liver cirrhosis; 13. Pregnancy or lactation. 14. Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
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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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Beijing Cancer Hopspital
Beijing, Beijing Municipality, 000000, China
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