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A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors

ConditionHER2-positive Advanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDualityBio Inc.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • DB-1303/BNT323

    Biological/Vaccine

    Administered IV

  • Pertuzumab Injection

    Drug

    Administered IV

  • Ritonavir

    Drug

    Administered oral

  • Itraconazole

    Drug

    Administered oral

Treatment groups

796 Participants
are divided into 24 treatment groups

24

Treatment groups

See each treatment group below.

Group A: DB-1303/BNT323 Dose Level 1Experimental treatment 1 intervention
Group B: DB-1303/BNT323 Dose Level 2Experimental treatment 1 intervention
Group C: DB-1303/BNT323 Dose Level 3Experimental treatment 1 intervention
Group D: DB-1303/BNT323 Dose Level 4Experimental treatment 1 intervention
Group E: DB-1303/BNT323 Dose Level 5Experimental treatment 1 intervention
Group F: DB-1303/BNT323 Dose Expansion 1Experimental treatment 1 intervention
Group G: DB-1303/BNT323 Dose Expansion 2Experimental treatment 1 intervention
Group H: DB-1303/BNT323 Dose Expansion 3Experimental treatment 1 intervention
Group I: DB-1303/BNT323 Dose Expansion 4Experimental treatment 1 intervention
Group J: DB-1303/BNT323 Dose Expansion 5Experimental treatment 1 intervention
Group K: DB-1303/BNT323 Dose Level 6Experimental treatment 1 intervention
Group L: DB-1303/BNT323 Dose Level 7Experimental treatment 1 intervention
Group M: DB-1303/BNT323 Dose Expansion 6Experimental treatment 1 intervention
Group N: DB-1303/BNT323 Dose Expansion 7Experimental treatment 1 intervention
Group O: DB-1303/BNT323 Dose Expansion 8Experimental treatment 1 intervention
Group P: DB-1303/BNT323 Dose Expansion 9Experimental treatment 1 intervention
Group Q: DB-1303/BNT323 Dose Expansion 10Experimental treatment 3 interventions
Group R: DB-1303/BNT323 Dose Expansion 11Experimental treatment 1 intervention
Group S: DB-1303/BNT323 Dose Expansion 12Experimental treatment 2 interventions
Group T: DB-1303/BNT323 Dose Expansion 13Experimental treatment 1 intervention
Group U: DB-1303/BNT323 Dose Expansion 14Experimental treatment 1 intervention
Group V: DB-1303/BNT323 Dose Expansion 15Experimental treatment 1 intervention
Group W: DB-1303/BNT323 Dose Expansion 16Experimental treatment 1 intervention
Group X: DB-1303/BNT323 Dose Expansion 17Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0.

Percentage of participants in Part 1 with DLTs

Time frame
up to 21 days after C1D1
2

Phase 1: Percentage of participants with AEs in Part 1 graded according to NCI CTCAE v5.0

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).

Time frame
Up to Safety Follow-Up visit, approximately 35 days post-treatment
3

Phase 1: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.

Percentage of Participants with SAEs in Part 1 graded according to NCI CTCAE v5.0

Time frame
Up to follow-up period, approximately 1 year post-treatment
4

Phase 1: Maximum Tolerated Dose (MTD) of DB-1303

MTD on the data collected during Part 1

Time frame
Up to Safety Follow-Up visit, approximately 35 days post-treatment

Secondary outcomes

1

Phase 1 & Phase 2: Pharmacokinetic-AUC

Area under the concentration-time curve from time 0 to infinity of DB-1303

Time frame
Up to safety follow up visit, approx. 35 days post-treatment
2

Phase 1 & Phase 2: Pharmacokinetic-Cmax

Maximum observed plasma concentration (Cmax) of DB-1303

Time frame
Up to safety follow up visit, approx. 35 days post-treatment
3

Phase 1 & Phase 2: Pharmacokinetic-Tmax

Time to Cmax of DB-1303

Time frame
Up to safety follow up visit, approx. 35 days post-treatment
4

Phase 1 & Phase 2: Pharmacokinetic-T1/2

Terminal elimination half-life

Time frame
Up to safety follow up visit, approx. 35 days post-treatment

Other outcomes

Sponsors and contacts

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

DualityBio Inc.

Lead sponsor

BioNTech SE

Collaborator

Source ClinicalTrials.gov
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