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Closed (no longer recruiting)Last updated: 2 February 2024

BAT: This phase I study is seeking to determine the best dose level and safety of a new targeted therapy (BAT6021) alone, and in combination with another targeted therapy (BAT1308), in people with locally advanced, recurrent, or metastatic incurable solid cancersA Phase 1, Multi-Center, Open-Label Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT6021 as Mono Therapy or in Combination With BAT1308 in Patients With Advanced Solid Tumors

Clinical summary

Summary

This dose escalation and expansion study is evaluating how safe and tolerable BAT6021 is alone, or in combination with 1308, in people with advanced solid cancers for whom standard therapy does not exist, has proven to be ineffective or intolerable, or is considered inappropriate. Eligible participants will be assigned to either receive BAT6021 alone or in combination with BAT1308, at varying dose levels depending on the assigned cohort. Both treatments will be administered via intravenous infusion. In cohorts receiving BAT6021 alone, dose levels being studied are: 10mg, 30mg, 100mg, 300mg, 600mg and 900mg. In cohorts receiving BAT6021 plus BAT1308, dose levels being studied are: 100mg BAT6021 + 300mg BAT1308, 300mg BAT6021 + 300mg BAT1308, and 600mg BAT6021 + 300mg BAT1308.

Conditions

This trial is treating patients with advanced solid cancers

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

Trial Acronym

BAT

More information

Trial Identifiers

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Trial sponsor

Bio-Thera Solutions

Scientific Title

A Phase 1, Multi-Center, Open-Label Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT6021 as Mono Therapy or in Combination With BAT1308 in Patients With Advanced Solid Tumors

Eligibility

Inclusion

  1. Able to give voluntary informed consent and understand the study and are willing to follow and complete all the test procedures.
  2. Aged ≥ 18 years.
  3. Life expectancy ≥ 3 months.
  4. ECOG performance status ≤ 1.
  5. Histologically/cytologically confirmed, locally advanced unresectable or metastatic solid tumors that are refractory to standard therapy, or for whom no standard therapy exists.
  6. Has measurable disease per RECIST v1.1. that was not in a prior radiation or other locally treated area, unless imaging-based progression has been clearly documented following radiation or other local therapy.

Exclusion

  1. Females who are pregnant or nursing.
  2. Receiving concurrent anticancer therapy or investigational therapy (including chemotherapy, radiation therapy, surgery, immunotherapy, hormonal therapy, targeted therapy, biologic therapy).
  3. Has remaining AEs > Grade 1 from prior antitumor treatment as per CTCAE v5.0, with the exception of alopecia.
  4. Participants with primacy central nervous system (CNS) malignancy, symptomatic CNS metastases, meningeal metastases or leptomeningeal disease are not allowed. Note: Participants with asymptomatic CNS metastases are eligible if clinically controlled, which is defined as 1) ≥ 4 weeks of stable neurologic function following CNS-directed therapy prior to Screening, 2) no evidence of CNS disease progression as determined by radiographic imaging ≥ 4 weeks prior to Screening, 3) ≥ 2 weeks from discontinuation of anti-seizure and steroid therapies (receiving prednisone ≤ 10mg or equivalent steroid therapies is allowed) prior to Screening.
  5. Had major surgery within 28-days of the Screening Visit. Note: Participants who have undergone a non-major surgical procedure ≥ 28 days prior to Screening must have recovered adequately from the toxicity and/or complications from the intervention before administration of the first dose of study drugs.
  6. History of tissue or organ transplantation.
  7. History of severe infection deemed clinically significant by the PI or designee within 4 weeks or signs and symptoms of any active infection within 2 weeks prior to the first dose of study drugs.
  8. History of human immunodeficiency virus (HIV) infection or history of autoimmune diseases.
  9. Active hepatitis B or C. Note: Hepatitis B virus (HBV) carriers without active disease (HBV DNA titer < 1000 copies/mL or 200 IU/mL) or cured Hepatitis C (negative HCV RNA test) may be enrolled.

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

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Closed hospitals

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