A Study of DB-1202 Monotherapy in Advanced Solid Tumors

Advanced Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05785728
• Other study ID #: DB-1202-O-1001
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: June 28, 2023
• Est. completion date: February 28, 2024

Study information

• Verified date: March 2023
• Source: DualityBio Inc.
• Contact: Jenny Y Li
• Phone: 16502379339
• Email: jenny.li[@]dualitybiologics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor

Intervention

Drug:
• DB-1202
Administered I.V.

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
DualityBio Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Maximum Tolerated Dose (MTD) of DB-1202	MTD on the data collected during Part 1	12 months
Primary	Phase 1: Recommended Phase 2 Dose (RP2D) of DB-1202	RP2D of DB-1202 based on the data collected during Part 1	12 months
Primary	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
Primary	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
Primary	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	Phase 1 & Phase 2a: Pharmacokinetic-AUC	Area under the concentration-time curve from time 0 to infinity of DB-1202	within 8 cycles (each cycle is 21 days)
Secondary	Phase 1 & Phase 2a: Pharmacokinetic-Cmax	Maximum observed plasma concentration (Cmax) of DB-1202	within 8 cycles (each cycle is 21 days)
Secondary	Phase 1 & Phase 2a: Pharmacokinetic-Tmax	Time to Cmax of DB-1202	within 8 cycles (each cycle is 21 days)
Secondary	Phase 1 & Phase 2a: Pharmacokinetic-T1/2	Terminal elimination half-life	within 8 cycles (each cycle is 21 days)