A Study of DB-1202 Monotherapy in Advanced Solid Tumors

NCT ID: NCT05785728

Last Updated: 2023-03-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-28
• Study Completion Date: 2024-02-28

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.

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.

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

DB-1202

Intervention Type: DRUG

Administered I.V.

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

Group Type: EXPERIMENTAL

DB-1202

Intervention Type: DRUG

Administered I.V.

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

Group Type: EXPERIMENTAL

DB-1202

Intervention Type: DRUG

Administered I.V.

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

Group Type: EXPERIMENTAL

DB-1202

Intervention Type: DRUG

Administered I.V.

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

Group Type: EXPERIMENTAL

DB-1202

Intervention Type: DRUG

Administered I.V.

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

Group Type: EXPERIMENTAL

DB-1202

Intervention Type: DRUG

Administered I.V.

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.

Group Type: EXPERIMENTAL

DB-1202

Intervention Type: DRUG

Administered I.V.

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.

Group Type: EXPERIMENTAL

DB-1202

Intervention Type: DRUG

Administered I.V.

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.

Group Type: EXPERIMENTAL

DB-1202

Intervention Type: DRUG

Administered I.V.

Interventions

DB-1202

Administered I.V.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female at least 18 years old.

2. 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.

3. Is capable of comprehending study procedures and risks outlined in the informed consent and is willing to provide written consent.

4. Has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1.

5. At least one measurable lesion as assessed by the investigator according to response evaluation criteria in solid tumors (RECIST) version 1.1 criteria.

6. Has adequate organ function within 7 days prior to initiation of the first Treatment Cycle

7. Platelet count ≥ 100 000/mm3

8. Hemoglobin (Hb) ≥ 8.5 g/dL

9. Absolute neutrophil count (ANC) ≥ 1500/mm3

10. Creatinine ≤ 1.5 × upper limit of normal (ULN), or

11. Creatinine clearance ≥ 60 mL/min (modification Cockcroft-Gault equation)

Exclusion Criteria

1. Has a medical history of symptomatic chronic heart failure (CHF) (New York Heart Association [NYHA] classes II-IV) or serious cardiac arrhythmia requiring treatment.

2. Has a medical history of myocardial infarction or unstable angina within 6 months before Day 1.

3. Has a QTc prolongation to > 470 millisecond (ms) based on a 12-lead electrocardiogram (ECG) in triplicate.

4. 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.

5. Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).

6. History of primary immunodeficiency.

7. History of allogeneic organ transplant.

8. Has an uncontrolled infection requiring IV injection of antibiotics, antivirals, or antifungals.

9. Known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection.

10. 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.

11. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DualityBio Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raymond Zhao

Role: STUDY_DIRECTOR

DualityBio Inc.

Locations

Fudan University Shanghai Cancer Center

Shanghai, , China

Countries

China

Central Contacts

Jenny Y Li

Role: CONTACT

jenny.li@dualitybiologics.com

16502379339

Ren Y Yue

Role: CONTACT

ren.yue@dualitybiologics.com

Facility Contacts

Jian Zhang, PhD

Role: primary

Syner2000@163.com

Other Identifiers

DB-1202-O-1001

Identifier Type: -

Identifier Source: org_study_id