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.
Treatment: BNT326 · Pumitamig · Itraconazole · Paroxetine — 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.
Check if I qualifyExtracted 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
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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