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OncoMatch/Clinical Trials/NCT07070232

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

Is NCT07070232 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including BNT326 and Pumitamig for advanced solid tumor.

Phase 1/2RecruitingBioNTech SENCT07070232Data as of May 2026

Treatment: BNT326 · Pumitamig · Itraconazole · ParoxetineThis 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.

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Extracted eligibility criteria

Cancer type

Tumor Agnostic

Biomarker criteria

Required: EGFR sensitizing mutation (Exon 21-L858R and 19del)

documented positive test results for an EGFR-sensitizing mutation (EGFR-sensitizing mutation Exon 21-L858R and 19del)

Required: HER2 (ERBB2) negative

breast cancer that is documented as HER2-negative

Required: EGFR no actionable genomic alterations

no actionable genomic alterations, such as EGFR mutations, anaplastic lymphoma kinase rearrangements, or other genomic alterations for which targeted molecular therapies are available

Required: ALK no actionable genomic alterations

no actionable genomic alterations, such as EGFR mutations, anaplastic lymphoma kinase rearrangements, or other genomic alterations for which targeted molecular therapies are available

Allowed: BRAF mutation

for participants with human gene that encodes a protein called B-Raf (BRAF) gene mutant melanoma, a prior treatment regimen that included vemurafenib, dabrafenib, or another BRAF gene inhibitor

Allowed: HER2 (ERBB2) expression positive

HER2-expression positive subgroup

Allowed: ESR1 negative

HR-negative or HR-positive

Allowed: PR (PGR) negative

HR-negative or HR-positive

Disease stage

Required: Stage IV, LOCALLY RECURRENT

Metastatic disease required

Have histologic or cytologic documented advanced disease, either at relapse or upon diagnosis of metastatic disease

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Max 3 prior lines
Min 1 prior line

Must have received: PD-1 inhibitor — advanced/metastatic melanoma

must have previously received a PD-1 or PD-L1 inhibitor

Must have received: BRAF inhibitor (vemurafenib, dabrafenib) — BRAF mutant melanoma

for participants with BRAF gene mutant melanoma, a prior treatment regimen that included vemurafenib, dabrafenib, or another BRAF gene inhibitor with or without mitogen-activated protein kinase protein inhibitor

Must have received: EGFR tyrosine kinase inhibitor — EGFR-mutant NSCLC

must include treatment with an approved EGFR Tyrosine Kinase Inhibitors (TKI), with at least one being a third-generation EGFR TKI

Must have received: platinum-based chemotherapy — NSCLC, cervical cancer

must have received platinum-based chemotherapy

Must have received: anti-PD-1 therapy — cervical cancer

with or without an anti-PD-(L)1 agent

Must have received: bevacizumab (bevacizumab) — cervical cancer

with or without an anti-PD-(L)1 agent and bevacizumab

Must have received: HER2-targeted therapy — HER2-positive gastric/GEJ cancer

including a HER2-targeted agent in accordance with local SoC

Cannot have received: topoisomerase I inhibitor (topotecan, irinotecan, deruxtecan)

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

Cannot have received: anti-VEGF (bevacizumab, ramucirumab)

history of intolerance to treatment with an anti-VEFG, anti-PD-1/PDL-1, or similar substance, including, but not limited to, bevacizumab, ramucirumab, atezolizumab, pembrolizumab, nivolumab, or other related therapies

Cannot have received: anti-PD-1 therapy (atezolizumab, pembrolizumab, nivolumab)

history of intolerance to treatment with an anti-VEFG, anti-PD-1/PDL-1, or similar substance, including, but not limited to, bevacizumab, ramucirumab, atezolizumab, pembrolizumab, nivolumab, or other related therapies

Lab requirements

Blood counts

adequate organ and bone marrow function (as specified in the protocol)

Kidney function

adequate organ and bone marrow function (as specified in the protocol)

Liver function

adequate organ and bone marrow function (as specified in the protocol)

Cardiac function

LVEF <50% by either echocardiography or multi-gated acquisition (scanning) within 28 days before randomization/enrollment [excluded]

adequate organ and bone marrow function (as specified in the protocol) within 7 days before randomization/enrollment; LVEF <50% by either echocardiography or multi-gated acquisition (scanning) within 28 days before randomization/enrollment [excluded]

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of California San Francisco · San Francisco, California
  • Hartford Healthcare · Hartford, Connecticut
  • Yale University · New Haven, Connecticut
  • Florida Cancer Specialists · Sarasota, Florida
  • Moffitt Cancer Center · Tampa, Florida

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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