Protocol No.UW25016
BNT326-01
Principal InvestigatorCZERLANIS, CHERYL
PhaseI/II
Age GroupAdult
ClinicalTrials.GovNCT07070232 (Click to jump to clinicaltrials.gov)
Management Group(s) Early Phase

Title
A Phase I/II, Open-Label, Adaptive Two-Part Trial to Evaluate the Safety, Efficacy, Optimal Dose and Pharmacokinetics of BNT326 as Monotherapy and in Combination With Cancer Immunotherapies in Participants With Advanced Solid Tumors

Description
Both parts (Part 1 and Part 2) will start enrolling study participants independent of each other.

In Part 1, participants with histologically or cytologically confirmed advanced solid tumors will receive BNT326 monotherapy in the following cohorts:



    Cohort 1A: Cutaneous melanoma (second-line or higher [2L+]).

    Cohort 1B: Actionable oncogenic alterations (AGA)-negative non-small cell lung cancer (NSCLC) 2L+.

    Cohort 1C: Epithelial growth factor receptor mutated (EGFRm) NSCLC 2L+.

    Cohort 1D: Rare melanoma (acral/uveal/mucosal melanoma).

    Cohort 1E: Other advanced solid tumors.

    Cohort 1F (drug-drug interaction [DDI] Cohort): Advanced solid tumors.

In Part 2, BNT326 will be studied in combination with other immunotherapeutic agents. The first combination treatment will be BNT326 with BNT327. The following cohorts are planned:


    Cohort 2A: Cutaneous melanoma 2L+.

    Cohort 2B: Human epidermal growth factor receptor 2 (HER2)-negative breast cancer.

Participants in Cohorts 1A, 1B, and 1C will be randomized to one of two dose levels of BNT326 in a 1:1 ratio. The sponsor may choose to open a dose randomization cohort in Cohort 2A for further dose optimization after dose escalation. No randomization is planned for Cohorts 1D, 1E, 1F, and 2B.

Objective
This study will evaluate the safety, efficacy, optimal dose, and pharmacokinetics (PK) of BNT326 as monotherapy (Part 1) and as combination treatment with immunotherapeutic agents (Part 2) in participants with histologically or cytologically confirmed solid tumors that are advanced (i.e., either metastatic or recurrent tumors with no further definitive treatment possible) and/or have relapsed/progressed after prior therapy.

Treatment The study will consist of a screening period, a treatment period, a safety follow-up period, an efficacy follow-up period, and a long-term survival follow-up period. Study treatment will be continued for up to 24 months or until disease progression, withdrawal of consent, termination of the study by the sponsor, or unacceptable toxicity. For each participant, the treatment and follow-up periods are projected to be completed within ~38 months (Part 1) and ~48 months (Part 2), unless participants are continuing to benefit from treatment per investigator's recommendation and upon sponsor approval.

Key Eligibility For full study eligibility, see this study's ClinicalTrials.gov record.

Applicable Disease Sites
Anal; Bladder; Brain/Central Nervous System; Breast; Cervix; Colon and Rectum; Endocrine cancers; Esophagus; Gastrointestinal cancers, other; Genitourinary cancers, other; Head and Neck; Ill-Defined Sites; Kidney; Liver; Lung; Melanoma/Skin cancer; Ovary; Pancreas; Prostate; Sarcoma; Stomach; Thyroid; Unknown Sites; Uterus

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital