A Study of HDM2005 in Patients With Relapsed/Refractory B-cell Lymphoma and Advanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
About this trial
This is a first-in-human (FIH) study to evaluate the safety and preliminary efficacy of experimental drug HDM2005 in patients with relapsed/refractory B-cell lymphoma and advanced solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Agree to follow the study treatment protocol and visit schedule, enroll voluntarily and sign a written informed consent;
Male or female aged ≥ 18 years at the time of signing the ICF;
B-cell lymphoma: ECOG performance status of 0-2;
Advanced solid tumors: ECOG performance status of 0-1;
Disqualifiers
B-cell lymphoma: known central nervous system (CNS) involvement .
Advanced solid tumors: Patients with active brain metastases (defined as stable for < 4 weeks, or symptomatic, or requiring antiepileptic drug/hormonal therapy, or meningeal metastases);
Subjects with prior allogeneic HSCT who have developed acute graft-versus-host disease (GVHD) or persistent evidence of chronic GVHD (as manifested by ≥ Grade 2 serum bilirubin, ≥ Grade 3 skin involvement, or ≥ Grade 3 diarrhea or receiving systemic immunosuppressive therapy/prophylaxis for GVHD);
Subjects have another primary malignancy ,with the following exceptions: adequately treated non-melanoma skin cancer without evidence of disease recurrence and adequately treated carcinoma in situ without evidence of disease recurrence,et al;
Trial design
Design model
Sequential
Treatments tested in this trial
HDM2005
DrugHDM2005 will be administered via IV infusion.
Treatment groups
111 Participants
are divided into 1 treatment groupGroup A: HDM2005Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of dose limiting toxicity (DLT) events (for dose escalation phase)
DLT will be determined by definition during the DLT observation period.
Time frame
up to 21 days following first dose2
Incident and severity of adverse events(for dose escalation phase)
The safety profile of HDM2005 will be assessed by monitoring the adverse events (AE) per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
Time frame
Until 28 days after the last dose or initiation of a new antineoplastic therapy, whichever occurs first3
Objective Response Rate (ORR)(for dose expansion phase)
Objective response rate (ORR), which includes best response of complete response (CR) or partial response (PR) as assessed by the investigator.
Time frame
Until withdrawal of consent, loss to follow-up, initiation of other new antineoplastic therapy, end of study, or study termination by the sponsor, whichever occurs first (up to approximately 3.5 years)4
Recommended Phase 2 Dose (RP2D) (for dose expansion phase)
The selection of RP2D will be based on consideration of overall safety information together with available pharmacokinetic,E-R relationships, and efficacy data.
Time frame
Approximately 3.5 yearsSecondary outcomes
1
Plasma concentration of HDM2005, total antibody and the free MMAE
Plasma concentration of HDM2005, total antibody and the free MMAE will be reported for each arm.
Time frame
up to 28 days following last dose2
Immunogenicity
Number and percentage of anti-drug antibody (ADA)-positive patients will be assessed.
Time frame
up to 28 days following last dose3
Incident and severity of adverse events(for dose expansion phase)
The safety profile of HDM2005 will be assessed by monitoring the adverse events (AE) per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
Time frame
Until 28 days after the last dose or initiation of a new antineoplastic therapy, whichever occurs first4
Objective Response Rate (ORR)(for dose escalation phase)
Objective response rate (ORR), which includes best response of complete response (CR) or partial response (PR) as assessed by the investigator.
Time frame
Approximately 3.5 yearsSponsors and contacts
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Source ClinicalTrials.gov