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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 (Sep 2026). This Phase 1/2 trial studies multiple treatments including BNT326 and Pumitamig for advanced solid tumor.

Phase 1/2RecruitingBioNTech SENCT07070232Data as of Sep 2026Location: International · 8 countries

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

Treatments studied

Other

BNT326PumitamigItraconazoleParoxetine

Cancer type

Tumor Agnostic

Biomarker criteria

Required: EGFR sensitizing mutation

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

Required: EGFR l858r

EGFR-sensitizing mutation Exon 21-L858R

Required: EGFR exon 19 deletion

EGFR-sensitizing mutation 19del

Required: HER2 (ERBB2) expression (HER2-negative)

recurrent unresectable or metastatic breast cancer that is documented as HER2-negative

Required: ESR1 expression (HR-positive)

either HR-negative or HR-positive per American Society of Clinical Oncology/College of American Pathologists guidelines

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: anti-PD-1 therapy — melanoma (cohort 1A, 1D)

Participants must have previously received a PD-1 or PD-L1 inhibitor...and have experienced progression during or after the previous treatment or discontinued from prior therapy due to intolerance

Must have received: BRAF inhibitor (vemurafenib, dabrafenib) — BRAF mutant melanoma (cohort 1A)

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...and have experienced progression during or after the previous treatment or discontinued from prior therapy due to intolerance

Must have received: EGFR tyrosine kinase inhibitor — advanced/metastatic NSCLC (cohort 1C)

must include treatment with an approved EGFR Tyrosine Kinase Inhibitors (TKI), with at least one being a third-generation EGFR TKI...have experienced progression during or after treatment or discontinued from prior therapy due to intolerance

Must have received: platinum-based chemotherapy — advanced/metastatic NSCLC (cohort 1B)

have experienced relapse or progression during or after treatment with standard systemic therapy including platinum-based chemotherapy and/or immune checkpoint inhibitor in the advanced/metastatic setting or discontinued from prior therapy due to intolerance

Must have received: immune checkpoint inhibitor — advanced/metastatic NSCLC (cohort 1B)

have experienced relapse or progression during or after treatment with standard systemic therapy including platinum-based chemotherapy and/or immune checkpoint inhibitor in the advanced/metastatic setting or discontinued from prior therapy due to intolerance

Must have received: platinum-based chemotherapy — metastatic/recurrent cervical cancer (cohort 1G/2F)

Must have received platinum-based chemotherapy, with or without an anti-PD-(L)1 agent and bevacizumab for metastatic/recurrent disease, unless the patient is not a candidate in the opinion of the treating physician

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-vascular endothelial growth factor therapy (bevacizumab, ramucirumab)

history of intolerance to treatment with an anti-vascular endothelial growth factor...including, but not limited to, bevacizumab, ramucirumab

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

history of intolerance to treatment with...anti-PD-1/PDL-1...including, but not limited to, atezolizumab, pembrolizumab, nivolumab

Lab requirements

Blood counts

adequate organ and bone marrow function (as specified in the protocol) within 7 days before randomization/enrollment

Liver function

Child-Pugh class B or C cirrhosis excluded

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; Child-Pugh class B or C cirrhosis [excluded]; LVEF <50% [excluded]

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

US trial sites

  • Mayo Clinic Arizona · Phoenix, Arizona
  • University of California San Francisco · San Francisco, California
  • Hartford Healthcare · Hartford, Connecticut
  • Yale University · New Haven, Connecticut
  • Florida Cancer Specialists · Sarasota, Florida

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT07070232 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior topoisomerase I inhibitor, anti-vascular endothelial growth factor therapy, anti-PD-1 therapy disqualifies patients from enrollment.

Does this trial require EGFR?

Yes, EGFR sensitizing mutation is a required biomarker for enrollment.

Does this trial require EGFR?

Yes, EGFR l858r is a required biomarker for enrollment.

Does this trial require EGFR?

Yes, EGFR exon 19 deletion is a required biomarker for enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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