BAT8008 injection for adults with advanced solid tumors to find a safe dose and how the drug is handled by the body
Official title: A Multicenter, Open Phase I Clinical Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Initial Efficacy of BAT8008 for Injection in Patients With Advanced Solid Tumor
Run by Bio-Thera Solutions · NCT05620017 · Data updated 2026-11-12
This study will test BAT8008 in adults with advanced solid tumors to find a safe dose and see how the body processes the drug.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 182 (estimated) |
| Sponsor | Bio-Thera Solutions Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 2 sites (Chongqing, Chongqing Municipality and 1 other locations) |
| Status | Recruiting |
| Started | November 30, 2022 |
| Main results expected | May 31, 2027 |
| Study ends | May 31, 2027 |
| Registry record updated | February 9, 2026 |
| Trial ID | NCT05620017 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with histologically or cytologically confirmed advanced or metastatic epithelial-derived solid tumors who have failed or declined standard therapies, have at least one RECIST 1.1 measurable lesion, ECOG 0–1, adequate organ and marrow function, and agree to provide tumor tissue and use contraception are ideal candidates.
✕Probably not a fit
Patients with non-epithelial tumors, ECOG performance status ≥2, inadequate organ or bone marrow function, no measurable disease, or those unable/unwilling to attend the Chinese study sites or provide tumor tissue are unlikely to qualify or benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, open-label Phase 1 dose-escalation and dose-expansion study of BAT8008 given by injection to adults with advanced epithelial-derived solid tumors. Rapid titration followed by a conventional 3+3 escalation design will be used to identify dose-limiting toxicities and the maximum tolerated dose, followed by expansion cohorts at selected doses. Safety, tolerability, and pharmacokinetic (PK) profiles will be collected, and archived or fresh tumor tissue samples will be obtained when available. The trial aims to recommend a dose for subsequent clinical development based on safety and PK data.
Why it matters
Potential benefit: If successful, the study could identify a tolerable dose and dosing plan that enables later trials to test whether BAT8008 provides clinical benefit for patients with advanced solid tumors.
How similar studies have gone: Dose-escalation designs like rapid titration and 3+3 are commonly used and have successfully identified safe doses for many first-in-human oncology agents, but BAT8008 itself appears to be a first-in-human/early clinical evaluation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: All of the following items could be meet to be enrolled the study 1. Age ≥18 years old, both sexes; 2. Voluntarily sign the informed consent; 3. Patients with advanced or metastatic epithelial-derived solid tumors that have been histopathologically or cytologically confirmed, have failed or not been treated with standard therapy, have been intolerant to or have refused standard therapy. 4. According to RECIST1.1, there is at least one measurable tumor lesion; 5. The Eastern Collaborative Oncology Group (ECOG) Performance Status score requires a score of 0 or 1; 6. Investigators assessed the expected survival of ≥12 weeks; 7. Adequate organ and bone marrow reserve function 8. Fertile female patients willing to use effective birth control/contraception to prevent pregnancy during the study period. Male patients must consent to use an effective method of contraception during the study; 9. Willing to provide previously archived or fresh tumor tissue samples 10. Able to understand the test requirements, willing and able to comply with the test and follow-up procedures. Exclusion Criteria: If you meet any of the following items, you will not be allowed to enroll this study : 1. Within 4 weeks before the first administration of the study drug, he has received experimental drug treatment or participated in clinical research of medical devices; 2. Have received other anti-tumor treatment within 4 weeks before the first administration of the study drug, such as chemotherapy, radiotherapy (palliative radiotherapy should be completed within 2 weeks before the first administration), targeted therapy/immunotherapy (at least 4 weeks or at least 5 half-life, whichever is shorter), hormone therapy (except alternative therapy); 3. Within 2 weeks before the first administration of the study drug, he has received the treatment of traditional Chinese medicine, Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, etc.) with anti-tumor effect; 4. Before the first administration of the study drug, AE (CTCAE5.0) caused by previous anti-tumor treatment was still greater than grade 1, except for the following conditions: a. alopecia; B pigmentation; c. The distal toxicity caused by chemotherapy and radiotherapy can not be further recovered after judgment; 5. Major surgery (excluding the operation for diagnosis) is required within 4 weeks before the first administration of the study drug or is expected to be performed during the study period; 6. Patients who have received Trop2 targeted therapy previously; 7. Those who have received the treatment containing exatecan or irinotecan and other topoisomerase I inhibitor drugs in the past and have experienced drug related AE ≥ grade 3 or treatment failure of topoisomerase I inhibitor; 8. Have a history of allograft cell or solid organ transplantation;
Where it's running
-
Affiliated Cancer Hospital of Chongqing University
Chongqing, Chongqing Municipality, China Recruiting -
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Principal investigator: Weier Song — Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Study coordinator: WeiNing Li
- Email: wnli@bio-thera.com
- Phone: 020-31702863（8028）
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.