BAT8008 injection for adults with advanced solid tumors to find a safe dose and how the drug is handled by the body

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

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: PHASE1
• Study type: Interventional
• Enrollment: 182 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Bio-Thera Solutions (industry)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 2 sites (Chongqing, Chongqing Municipality and 1 other locations)
• Trial ID: NCT05620017 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Chongqing, Chongqing Municipality and 1 other locations

• 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

Conditions: Advanced Solid Tumors