A Study of DB-1202 Monotherapy in Advanced Solid Tumors

Sponsor

DualityBio Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05785728

Collaborator

(none)

150

Enrollment

Location

Arms

Anticipated Duration (Months)

18.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1201 in subjects with advanced solid tumors.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumor	Drug: DB-1202	Phase 1/Phase 2

Detailed Description

This is a multicenter, non-randomized, open-label, multiple-dose, FIH study. The study consists of two parts: Part 1 adopts a rule based "3 + 3" design to identify MTD/RP2D; Part 2 is a dose expansion phase to confirm the safety, tolerability and efficacy in selected solid malignant tumors.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase 1/2, Multicenter, Open-label, First-in-human Study of DB-1202 Monotherapy in Patients With Advanced Solid Malignant Tumors to Evaluate the Tolerability, Safety, Pharmacokinetics and Antitumor Activity

Anticipated Study Start Date :

Jun 28, 2023

Anticipated Primary Completion Date :

Feb 28, 2024

Anticipated Study Completion Date :

Feb 28, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DB-1202 Dose Level 1 Enrolled Subjects will receive a single-dose of DB-1202 at Dose Level 1 on Day 1 of each cycle Q3W	Drug: DB-1202 Administered I.V.
Experimental: DB-1202 Dose Level 2 Enrolled Subjects will receive a single-dose of DB-1202 at Dose Level 2 on Day 1 of each cycle Q3W	Drug: DB-1202 Administered I.V.
Experimental: DB-1202 Dose Level 3 Enrolled Subjects will receive a single-dose of DB-1202 at Dose Level 3 on Day 1 of each cycle Q3W	Drug: DB-1202 Administered I.V.
Experimental: DB-1202 Dose Level 4 Enrolled Subjects will receive a single-dose of DB-1202 at Dose Level 4 on Day 1 of each cycle Q3W	Drug: DB-1202 Administered I.V.
Experimental: DB-1202 Dose Level 5 Enrolled Subjects will receive a single-dose of DB-1202 at Dose Level 5 on Day 1 of each cycle Q3W	Drug: DB-1202 Administered I.V.
Experimental: DB-1202 Dose Level 6 Enrolled Subjects will receive a single-dose of DB-1202 at Dose Level 6 on Day 1 of each cycle Q3W	Drug: DB-1202 Administered I.V.
Experimental: DB-1202 Dose Expansion 1 Enrolled Subjects with locally advanced or metastatic primary thyroid cancers with pathology of epithelial tumors that originated from thyroid follicular cells will be enrolled regardless of PD-L1 expression will receive initial dose of DB-1202 Q3W under a 21-day Treatment Cycle with RP2D.	Drug: DB-1202 Administered I.V.
Experimental: DB-1202 Dose Expansion 2 Enrolled Subjects in selected solid malignant tumors can be added will receive initial dose of DB-1202 Q3W under a 21-day Treatment Cycle with RP2D.	Drug: DB-1202 Administered I.V.
Experimental: DB-1202 Dose Expansion 3 Enrolled Subjects in selected solid malignant tumors can be added will receive initial dose of DB-1202 Q3W under a 21-day Treatment Cycle with RP2D.	Drug: DB-1202 Administered I.V.

Outcome Measures

Primary Outcome Measures

Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0 [up to 21 days after Cycle 1 Day 1]
Percentage of participants in Part 1 with DLTs
Phase 1: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0 [Up to follow-up period, approximately 1 year post-treatment]
Percentage of participants with AEs in Part 1 graded according to NCI CTCAE v5.0
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
Maximum Tolerated Dose (MTD) of DB-1202 [12 months]
MTD on the data collected during Part 1
Phase 1: Recommended Phase 2 Dose (RP2D) of DB-1202 [12 months]
RP2D of DB-1202 based on the data collected during Part 1
Phase 2a: Percentage of Participants with Treatment Emergent adverse events (TEAEs) as assessed by CTCAE v5.0. [Up to follow-up period, approximately 1 year post-treatment]
Percentage of participants with AEs in Part 2 graded according to NCI CTCAE v5.0
Phase 2a: 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
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 rating of CR and PR, for Part 2 only which was maintained ≥4 weeks

Secondary Outcome Measures

Phase 1 & Phase 2a: Pharmacokinetic-AUC [within 8 cycles (each cycle is 21 days)]
Area under the concentration-time curve from time 0 to infinity of DB-1202
Phase 1 & Phase 2a: Pharmacokinetic-Cmax [within 8 cycles (each cycle is 21 days)]
Maximum observed plasma concentration (Cmax) of DB-1202
Phase 1 & Phase 2a: Pharmacokinetic-Tmax [within 8 cycles (each cycle is 21 days)]
Time to Cmax of DB-1202
Phase 1 & Phase 2a: Pharmacokinetic-T1/2 [within 8 cycles (each cycle is 21 days)]
Terminal elimination half-life

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female at least 18 years old.
Has histologically or cytologically confirmed metastatic or locally advanced solid tumors for which no effective standard therapy existed or standard of care has failed or is not considered as an option.
Is capable of comprehending study procedures and risks outlined in the informed consent and is willing to provide written consent.
Has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1.
At least one measurable lesion as assessed by the investigator according to response evaluation criteria in solid tumors (RECIST) version 1.1 criteria.
Has adequate organ function within 7 days prior to initiation of the first Treatment Cycle
Platelet count ≥ 100 000/mm3
Hemoglobin (Hb) ≥ 8.5 g/dL
Absolute neutrophil count (ANC) ≥ 1500/mm3
Creatinine ≤ 1.5 × upper limit of normal (ULN), or
Creatinine clearance ≥ 60 mL/min (modification Cockcroft-Gault equation)

Exclusion Criteria:

Has a medical history of symptomatic chronic heart failure (CHF) (New York Heart Association [NYHA] classes II-IV) or serious cardiac arrhythmia requiring treatment.
Has a medical history of myocardial infarction or unstable angina within 6 months before Day 1.
Has a QTc prolongation to > 470 millisecond (ms) based on a 12-lead electrocardiogram (ECG) in triplicate.
Active or prior documented autoimmune disease within the past 2 years. NOTE: Subjects with a history of autoimmune thyroid disease are not excluded. Subjects with vitiligo or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
History of primary immunodeficiency.
History of allogeneic organ transplant.
Has an uncontrolled infection requiring IV injection of antibiotics, antivirals, or antifungals.
Known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection.
Is a lactating mother (women who are willing to temporarily interrupt breastfeeding will also be excluded), or pregnant as confirmed by pregnancy tests performed within 7 days prior to initiation of the first Treatment Cycle.
Male and female subjects who are unwilling to use adequate contraceptive methods (double barrier or intrauterine contraceptive) during the study and for at least 7 months after the last dose of study drug.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fudan University Shanghai Cancer Center	Shanghai		China	200120

Sponsors and Collaborators

DualityBio Inc.

Investigators

Study Director: Raymond Zhao, DualityBio Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

DualityBio Inc.

ClinicalTrials.gov Identifier:

NCT05785728

Other Study ID Numbers:

DB-1202-O-1001

First Posted:

Mar 27, 2023

Last Update Posted:

Mar 31, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by DualityBio Inc.

TGF-β

thyroid cancer

Study Results

No Results Posted as of Mar 31, 2023