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A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors

ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBioNTech SE

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged ≥18 years at the time of giving informed consent. Local laws will be followed if the age of consent is older.

Have histologic or cytologic documented advanced disease, either at relapse or upon diagnosis of metastatic disease. This requirement may be considered met when advanced disease derives from unequivocal progression of a previously biopsied site of disease (e.g., progression of residual tumor after concomitant chemo-radiation for Stage III NSCLC).

Have measurable disease defined by RECIST v1.1.

Have ECOG performance status of 0 or 1.

Disqualifiers

Have a history of intolerance to treatment with a topoisomerase I inhibitor or intolerance to an ADC that consists of a topoisomerase I inhibitor, including but not limited to topotecan, irinotecan, and deruxtecan (e.g., severe diarrhea).

Bleeding diathesis or active hemorrhage,

Active infection,

Child-Pugh class B or C cirrhosis,

Trial design

Design model

Sequential

Treatments tested in this trial

  • BNT326

    Drug

    Intravenous (IV) infusion

  • Pumitamig

    Drug

    IV infusion

  • Itraconazole

    Drug

    Oral administration

  • Paroxetine

    Drug

    Oral administration

Treatment groups

1,438 Participants
are divided into 18 treatment groups

18

Treatment groups

See each treatment group below.

Group A: Part 1 (Cohort 1A) - BNT326 monotherapyExperimental treatment 1 intervention
Group B: Part 1 (Cohort 1B) - BNT326 monotherapyExperimental treatment 1 intervention
Group C: Part 1 (Cohort 1C) - BNT326 monotherapyExperimental treatment 1 intervention
Group D: Part 1 (Cohort 1D) - BNT326 monotherapyExperimental treatment 1 intervention
Group E: Part 1 (Cohort 1E) - BNT326 monotherapyExperimental treatment 1 intervention
Group F: Part 1 (Cohort 1F, DDI) - BNT326 + itraconazoleExperimental treatment 2 interventions
Group G: Part 1 (Cohort 1F, DDI) - BNT326 + paroxetineExperimental treatment 2 interventions
Group H: Part 1 (Cohort 1G) - BNT326 monotherapyExperimental treatment 1 intervention
Group I: Part 2 (Cohort 2A dose escalation) - BNT326 + pumitamigExperimental treatment 2 interventions
Group J: Part 2 (Cohort 2A dose randomization/expansion) - BNT326 + pumitamigExperimental treatment 2 interventions
Group K: Part 2 (Cohort 2B dose escalation) - BNT326 + pumitamigExperimental treatment 2 interventions
Group L: Part 2 (Cohort 2B dose randomization/expansion) - BNT326 + pumitamigExperimental treatment 2 interventions
Group M: Part 2 (Cohort 2C) - Optional - BNT326 + pumitamigExperimental treatment 2 interventions
Group N: Part 2 (Cohort 2D1) - BNT326 monotherapyExperimental treatment 1 intervention
Group O: Part 2 (Cohort 2D2) - BNT326 + pumitamigExperimental treatment 2 interventions
Group P: Part 2 (Cohort 2E1) - BNT326 monotherapyExperimental treatment 1 intervention
Group Q: Part 2 (Cohort 2E2) - BNT326 + pumitamigExperimental treatment 2 interventions
Group R: Part 2 (Cohort 2F) - BNT326 + pumitamigExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Parts 1 and 2 - All cohorts except Cohort 1F - Occurrence of treatment emergent adverse events (TEAEs), treatment related adverse events (TRAEs), treatment emergent serious adverse events (TESAEs), and treatment related serious adverse events (TRSAEs)

By cohort and by dose in (Part 1), and by cohort and combination treatment regimen (in Part 2).

Time frame
from first dose of investigational medicinal product (IMP) up to 42 days (Part 1) and 90 days (Part 2) after the last dose of IMP or until a new systemic anti-cancer therapy is started, whichever occurs first (up to 26 months Part 1 or 27 months Part 2)
2

Parts 1 and 2 - All cohorts except Cohort 1F - Occurrence of dose interruption, reduction, and treatment discontinuations due to TEAEs

By cohort and by dose in (Part 1), and by cohort and combination treatment regimen (in Part 2)

Time frame
from first dose of IMP up to 42 days (Part 1) and 90 days (Part 2) after the last dose of IMP or until a new systemic anti-cancer therapy is started, whichever occurs first (up to 26 months Part 1 or 27 months Part 2)
3

Parts 1 and 2 - All cohorts except Cohort 1F - Confirmed overall response rate (ORR)

Defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) based on the investigator's assessment (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\]) is observed as best overall response. By cohort and by dose in (Part 1), and by cohort and combination treatment regimen (in Part 2).

Time frame
from the time of initiation of the first dose of IMP up to approximately 38 months (Part 1) and approximately 48 months (Part 2)
4

Part 2 - Occurrence of dose limiting toxicities (DLTs)

During the DLT observation period.

Time frame
from the time of initiation of the first dose of IMP up to 21 days

Secondary outcomes

1

Part 1 - Cohort 1F (DDI) only - Occurrence of TEAEs, TRAEs, TESAEs, and TRSAEs

By treatment, with and without itraconazole or paroxetine

Time frame
from the time of initiation of the first dose of IMP to 42 days after the last dose of IMP
2

Part 1 - Cohort 1F (DDI) only - Occurrence of dose interruption, reduction, and treatment discontinuations due to TEAEs

By cohort and dose, with and without itraconazole or paroxetine

Time frame
from the time of initiation of the first dose of IMP to 42 days after the last dose of IMP
3

Part 1 - Cohort 1F (DDI) only - Occurrence of clinically relevant changes from baseline for vital signs

Time frame
from the time of initiation of the first dose of IMP to 42 days after the last dose of IMP
4

Part 1 - Cohort 1F (DDI) only - Occurrence of clinically relevant changes from baseline for clinical laboratory tests

Time frame
from the time of initiation of the first dose of IMP to 42 days after the last dose of IMP

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BioNTech SE

Lead sponsor

BioNTech (Shanghai) Pharmaceuticals Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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