An Open-label Dose Escalation and Cohort Expansion Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and and Efficacy of DXC006 in Patients With Advanced Solid Tumors and Hematologic Malignancies

Hangzhou DAC Biotechnology Co., Ltd.1 site in 1 country110 target enrollmentJanuary 24, 2024

ConditionsAdvanced Solid Tumors Hematological Malignancies

InterventionsDXC006

DrugsDXC006

Overview

Phase: Phase 1
Intervention: DXC006
Conditions: Advanced Solid Tumors
Sponsor: Hangzhou DAC Biotechnology Co., Ltd.
Enrollment: 110
Locations: 1
Primary Endpoint: Number of participants that experienced dose limiting toxicities(DLTs) at given dose level.
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a phase I, open-label, first-in-human clinical study designed to evaluate the safety, tolerability, MTD, DLT, RP2D, the PK characteristics, preliminary anti-tumor activity, the immunogenicity of DXC006 in patients with a variety of solid tumors, including small cell lung cancer, multiple myeloma, and neuroblastoma, and hematological malignancies.

Detailed Description

Registry

clinicaltrials.gov

Start Date

January 24, 2024

End Date

December 31, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Hangzhou DAC Biotechnology Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The patient voluntarily signed the informed consent form and followed the protocol requirements.
•Gender is not limited.
•Age ≥ 18 years old.
•Expected survival time ≥ 3 months.
•The Eastern Cooperative Oncology Group (ECOG) score 0-
•Subjects may provide biopsy or archival tumor tissue samples for the central laboratory to confirm expression levels of Target protein.
•Patients with solid tumors or hematologic tumors who have failed standard therapy, including small cell lung cancer, multiple myeloma, neuroblastoma, etc..
•Patients who have received ASCT treatment must meet the following conditions:
•ASCT \> 100 days from start of study treatment.
•no active infection.

Exclusion Criteria

•Within 14 days before the first dose: received plasmapheresis; Treatment with \> 10 mg of prednisone or equivalent doses of systemic corticosteroids per day for more than 3 consecutive days (short-term use for the prevention of contrast allergy can be enrolled).
•Patients have received systemic anti-myeloma therapy or investigational drug therapy within 28 days or 5 half-lives (whichever is shorter) prior to the first dose; Radiotherapy within 14 days prior to the first dose.
•Patients have received monoclonal antibody therapy within 30 days before the first dose.
•Patients have received autologous hematopoietic stem cell transplantation within 100 days before the first dose.
•Patients who have undergone allogeneic hematopoietic stem cell transplantation (HSCT) or have a history of solid organ transplantation.
•Patients have received the same targeted therapy in the past (limited to phase Ia clinical trials).
•Patient has symptomatic brain metastases or meningeal metastases.
•The patient had symptomatic amyloidosis, active plasma cell leukemia, and active POEMS syndrome at the time of screening.
•There is evidence of cardiovascular risk, including any of the following: a. QTcF interval ≥ 470 ms (QT interval must be corrected by Fridericia formula \[QTcF\]). b. Evidence of currently clinically significant, untreated arrhythmias, including clinically significant electrocardiogram abnormalities such as degree 2 (Mobitz type II) or degree 3 atrioventricular conduction (AV) block. c. History of myocardial infarction, acute coronary syndrome (including unstable angina pectoris), coronary angioplasty, or stenting or bypass grafting within 6 months prior to screening. d. Grade III or IV heart failure(New York Heart Association Functional Grading System). e. Uncontrolled severe hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥ 100 mmHg).
•The patient has difficulty breathing or currently requires continuous oxygen therapy, or currently has active pneumonia or interstitial lung disease (except for mild cases as determined by the investigator).

Arms & Interventions

Experimental

Dose Escalation DXC006, Cohort Expansion DXC006

Intervention: DXC006

Outcomes

Primary Outcomes

Number of participants that experienced dose limiting toxicities(DLTs) at given dose level.

Time Frame: 28 days

Dose Limiting Toxicities (DLTs) In Order to Determine the Maximum Tolerated.

Number of participants with adverse events (AEs)

Time Frame: After first infusion of study drug, Through study completion an average of 1 year

The adverse events will be evaluated in accordance with CTCAE v5.0. The investigator shall assess the relationship between the events and investigational product.

Secondary Outcomes

Apparent volume of distribution(Vd)(Through study completion an average of 1 year)
Volume of distribution at steady state (Vss)(Through study completion an average of 1 year)
Maximum serum drug time（Tmax）(Through study completion an average of 1 year)
Terminal phase elimination half life (t½)(Through study completion an average of 1 year)
Area under the serum or plasma concentration time curve from 0 to the last measurable point (AUC0-t)(Through study completion an average of 1 year)
Area under the serum or plasma concentration time curve from 0 to infinity (AUC0-inf)(Through study completion an average of 1 year)
Clearance (CL)(Through study completion an average of 1 year)
Anti-drug antibodies (ADA)(Through study completion an average of 1 year)
Objective Response Rate (ORR)(From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year)
Duration of response (DOR)(From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year)
Progression Free Survival (PFS)(om date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year)
Maximum observed serum or plasma concentration (Cmax)(Through study completion an average of 1 year)
Overall Survival (OS)(From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year)