A Study of DB-1202 Monotherapy in Advanced Solid Tumors

NCT05785728 | Unknown Phase 1 FDA Drug

• 1 other identifier: DB-1202-O-1001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumor

Keywords

TGF-β; thyroid cancer

Outcome Measures

Primary Outcomes (8)

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

  Percentage of participants in Part 1 with DLTs

  up to 21 days after Cycle 1 Day 1

• Phase 1: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0

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

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

• 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

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

• Maximum Tolerated Dose (MTD) of DB-1202

  MTD on the data collected during Part 1

  12 months

• Phase 1: Recommended Phase 2 Dose (RP2D) of DB-1202

  RP2D of DB-1202 based on the data collected during Part 1

  12 months

• Phase 2a: Percentage of Participants with Treatment Emergent adverse events (TEAEs) as assessed by CTCAE v5.0.

  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 2a: Percentage participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.

  Percentage of participants with SAEs in Part 2 graded according to NCI CTCAE v5.0

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

• Percentage of Objective Response Rate (ORR) as assessed by RECIST 1.1.

  The percentage of subjects who had a best response rating of CR and PR, for Part 2 only which was maintained ≥4 weeks

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

Secondary Outcomes (4)

• Phase 1 & Phase 2a: Pharmacokinetic-AUC

  within 8 cycles (each cycle is 21 days)

• Phase 1 & Phase 2a: Pharmacokinetic-Cmax

  within 8 cycles (each cycle is 21 days)

• Phase 1 & Phase 2a: Pharmacokinetic-Tmax

  within 8 cycles (each cycle is 21 days)

• Phase 1 & Phase 2a: Pharmacokinetic-T1/2

  within 8 cycles (each cycle is 21 days)

Study Arms (9)

DB-1202 Dose Level 1

EXPERIMENTAL

Enrolled Subjects will receive a single-dose of DB-1202 at Dose Level 1 on Day 1 of each cycle Q3W

Drug: DB-1202

DB-1202 Dose Level 2

EXPERIMENTAL

Enrolled Subjects will receive a single-dose of DB-1202 at Dose Level 2 on Day 1 of each cycle Q3W

Drug: DB-1202

DB-1202 Dose Level 3

EXPERIMENTAL

Enrolled Subjects will receive a single-dose of DB-1202 at Dose Level 3 on Day 1 of each cycle Q3W

Drug: DB-1202

DB-1202 Dose Level 4

EXPERIMENTAL

Enrolled Subjects will receive a single-dose of DB-1202 at Dose Level 4 on Day 1 of each cycle Q3W

Drug: DB-1202

DB-1202 Dose Level 5

EXPERIMENTAL

Enrolled Subjects will receive a single-dose of DB-1202 at Dose Level 5 on Day 1 of each cycle Q3W

Drug: DB-1202

DB-1202 Dose Level 6

EXPERIMENTAL

Enrolled Subjects will receive a single-dose of DB-1202 at Dose Level 6 on Day 1 of each cycle Q3W

Drug: DB-1202

DB-1202 Dose Expansion 1

EXPERIMENTAL

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

DB-1202 Dose Expansion 2

EXPERIMENTAL

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

DB-1202 Dose Expansion 3

EXPERIMENTAL

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

Interventions

DB-1202 DRUG

Administered I.V.

DB-1202 Dose Expansion 1; DB-1202 Dose Expansion 2; DB-1202 Dose Expansion 3; DB-1202 Dose Level 1; DB-1202 Dose Level 2; DB-1202 Dose Level 3; DB-1202 Dose Level 4; DB-1202 Dose Level 5; DB-1202 Dose Level 6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• DualityBio Inc.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200120, China

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Raymond Zhao

  DualityBio Inc.

  STUDY DIRECTOR

Central Study Contacts

Jenny Y Li

CONTACT

16502379339; jenny.li@dualitybiologics.com

Ren Y Yue

CONTACT

ren.yue@dualitybiologics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: March 27, 2023
• Study Start: June 28, 2023
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: March 31, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)