A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors (NCT05150691) — USA Trial Details

Condition(s) studied

HER2-positive Advanced Solid Tumor

Investigational drug(s) / intervention(s)

DB-1303/BNT323 →Pertuzumab Injection →Ritonavir →Itraconazole →

DB-1303/BNT323: Administered IV

Pertuzumab Injection: Administered IV

Ritonavir: Administered oral

Itraconazole: Administered oral

Study summary

This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303/BNT323 in subjects with advanced solid tumors that express HER2.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

No

Inclusion Criteria: * Has a pathologically documented HER2-positive or HER2-expressing (except for cohort 2h where the requirement is HER2-null), advanced/unresectable, recurrent, or metastatic malignant solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available. * At least 1 measurable lesion (per RECIST 1.1) * Provide signed informed consent * ECOG performance status (PS) of 0-1. * LVEF ≥ 50% by ECHO or MUGA * Adequate organ functions * Provide pre-existing diagnosis of HER2 status or resected tumor samples or undergo fresh tumor biopsy for HER2 testing. * Life expectancy of ≥ 3 months. Additional Inclusion Criteria for Part 2 Expansion Group 9: 1\. Has pathologically documented advanced/unresectable, recurrent, or metastatic EC (including UCS and USPC) and has progressed on or after at least 1 line of systemic treatment including platinum-based therapy and exposure to ICI but no more than prior 3 lines of therapy for advanced/unresectable, or metastatic disease. Note: endocrine therapy will not qualify as a systemic therapy line. Exclusion Criteria: * History of symptomatic CHF (New York Heart Association \[NYHA\] classes II-IV) or serious cardiac arrhythmia requiring treatment. * History of myocardial infarction or unstable angina within 6 months before Day 1. * Average QTcF \> 450 ms in males and \> 470 ms in females * History of clinically significant lung diseases * Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals. * HIV infection with AIDS defining illness or active viral hepatitis. * Clinically active brain metastases * Unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0, Grade ≤ 1 or baseline. * A known hypersensitivity to either the drug substances or inactive ingredients in the drug product. * Part 2 (expansion) Only:Multiple primary malignancies within 3 years, except adequately resected non- melanoma skin cancer, curatively treated in-situ disease, other solid tumors curatively treated, or contralateral breast cancer.

Primary outcome measure(s)

Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0. — up to 21 days after C1D1
Percentage of participants in Part 1 with DLTs
Phase 1: Percentage of participants with AEs in Part 1 graded according to NCI CTCAE v5.0 — Up to Safety Follow-Up visit, approximately 35 days post-treatment
Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) or Treatment Emergent Adverse Event of Special Interest include those \>/= G3 leading to dose reduction, interruption or discontinuation as assessed by CTCAE v5.0, abnormal vital signs, abnormal 12-lead ECGs, abnormal safety laboratory tests, abnormal ECOG PS, abnormal ECHO/MUGA (LVEF).
Phase 1: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0. — Up to follow-up period, approximately 1 year post-treatment
Percentage of Participants with SAEs in Part 1 graded according to NCI CTCAE v5.0
Phase 1: Maximum Tolerated Dose (MTD) of DB-1303 — Up to Safety Follow-Up visit, approximately 35 days post-treatment
MTD on the data collected during Part 1
Phase 1: Recommended Phase 2 Dose (RP2D) of DB-1303 — Up to Safety Follow-Up visit, approximately 35 days post-treatment
RP2D of DB-1303 based on the data collected during Part 1
Percentage of participants with AEs in Part 2 graded according to NCI CTCAE v5.0 — Up to follow-up period, approximately 1 year post-treatment
Phase 2: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) or Treatment Emergent Adverse Event of Special Interest include those \>/= G3 leading to dose reduction, interruption or discontinuation as assessed by CTCAE v5.0, abnormal vital signs, abnormal 12-lead ECGs, abnormal safety laboratory tests, abnormal ECOG PS, abnormal ECHO/MUGA (LVEF).
Phase 2: Percentage participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0. — Up to follow-up period, approximately 1 year post-treatment
Percentage of participants with SAEs in Part 2 graded according to NCI CTCAE v5.0
Phase 2: Percentage of Objective Response Rate (ORR) as assessed by RECIST 1.1. — Up to follow-up period, approximately 1 year post-treatment
The percentage of subjects who had a best response of CR or PR, for Part 2 only which was maintained ≥4 weeks.
Phase 2 (Dose Expansion 10 only): To evaluate the effect of ritonavir on DB-1303 and P1003 PK in subjects with HER2-expressing, HER2-amplified, or HER2-mutated advanced solid malignant tumors — up to safety follow-up visit, approx. 35 days post-treatment
Maximum observed plasms concentration (Cmax) and Area under the concentration-time curve from 0 to infinity of DB-1303 and P1003 (+/- Ritonavir)
Phase 2 (Dose Expansion 10 only): To evaluate the effect of itraconazole on DB-1303 and P1003 PK in subjects with HER2-expressing, HER2-amplified, or HER2-mutated advanced solid malignant tumors. — up to safety follow-up visit, approx. 35 days post-treatment
Maximum observed plasms concentration (Cmax) and Area under the concentration-time curve from 0 to infinity of DB-1303 and P1003 (+/- Itraconazole)

Trial sites (102)

Facility	City	Region	Status
Helios Clinical Research	Cerritos	California	Active Not Recruiting
California Research Institute	Los Angeles	California	Active Not Recruiting
Sharp Memorial Hospital	San Diego	California	Active Not Recruiting
Washington Cancer Institute at MedStar Washington Hospital Center	Washington D.C.	District of Columbia	Active Not Recruiting
Advanced Research LLC	Coral Springs	Florida	Active Not Recruiting
The Oncology Institute of Hope and Innovation	Lakeland	Florida	Active Not Recruiting
D&H Cancer Research Center LLC	Margate	Florida	Active Not Recruiting
HCA Mercy Hospital	Miami	Florida	Withdrawn
BRCR Medical Center Inc.	Plantation	Florida	Active Not Recruiting
BRCR Medical Center Inc.	Tamarac	Florida	Active Not Recruiting
Southeastern Regional Medical Center, LLC	Newnan	Georgia	Active Not Recruiting
Kapi'olani Medical Center for Women and Children	Honolulu	Hawaii	Active Not Recruiting
University of Chicago	Chicago	Illinois	Active Not Recruiting
Women's Cancer Care	Covington	Louisiana	Withdrawn
Holy Cross Hospital	Silver Spring	Maryland	Withdrawn
Massachusetts General Hospital	Boston	Massachusetts	Active Not Recruiting
Beth Israel Deaconess Medical Center	Boston	Massachusetts	Active Not Recruiting
Profound Research LLC/Michigan Hematology & Oncology Consultants	Dearborn	Michigan	Withdrawn
David C. Pratt Cancer Center	St Louis	Missouri	Active Not Recruiting
Women's Cancer Center of Nevada	Las Vegas	Nevada	Withdrawn
Northwell Health	Lake Success	New York	Withdrawn
Laura & Isaac Perlmutter Cancer Center at NYC Langone Health	New York	New York	Active Not Recruiting
Memorial Sloan Kettering Cancer Center	New York	New York	Active Not Recruiting
North Shore Hematology Oncology Associate P.C. DBA New York Cancer and Blood Specialists	Shirley	New York	Active Not Recruiting
Regional Medical Oncology Center	Wilson	North Carolina	Withdrawn
Gabrail Cancer Center	Canton	Ohio	Active Not Recruiting
University of Oklahoma	Oklahoma City	Oklahoma	Active Not Recruiting
Rittenhouse Hematology Oncology	Philadelphia	Pennsylvania	Withdrawn
Thomas Jefferson University	Philadelphia	Pennsylvania	Active Not Recruiting
AHN West Penn Hospital	Pittsburgh	Pennsylvania	Active Not Recruiting
Tennessee Oncology	Nashville	Tennessee	Active Not Recruiting
Clinical Trial Network	Houston	Texas	Withdrawn
Oncology and Hematology of South Texas, PA	Laredo	Texas	Active Not Recruiting
NEXT Virginia	Fairfax	Virginia	Active Not Recruiting
Swedish Cancer Institute	Seattle	Washington	Active Not Recruiting
Scientia Clinical Research LTD	Randwick	New South Wales	Active Not Recruiting
Macquarie Clinical Trials Unit	Sydney	New South Wales	Active Not Recruiting
Integrated Clinical Oncology Network Pty Ltd (Icon)	South Brisbane	Queensland	Active Not Recruiting
Monash Health	Melbourne	Victoria	Active Not Recruiting
The first affiliated hospital of Bengbu medical college	Bengbu	Anhui	Recruiting

+ 62 more sites — see the full list on the official registry below.

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