A Study of HDM2005 in Patients With Advanced Solid Tumor

NCT07004296 | Recruiting Phase 1 FDA Drug

• 1 other identifier: HDM2005-103
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study evaluating the efficacy, safety, and pharmacokinetics ofHDM2005 in participants with metastatic solid tumors.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (5)

• Incidence of dose limiting toxicity (DLT) events (for dose escalation phase)

  DLT will be determined by definition during the DLT observation period.

  up to 21 days or 28 days following first dose

• 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.

  Until 28 days after the last dose or initiation of a new antineoplastic therapy, whichever occurs first.

• Progression-free survival(PFS)(for dose expansion phase)

  PFS, defined as the interval from the start of study treatment to the earlier of the first documentation of disease progression or death from any cause per RECIST, Version 1.1.

  Approximately 30 months

• 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.

  Approximately 18 months

• Recommended Phase 2 Dose (RP2D) (for dose expansion phase) Recommended Phase 2 Dose (RP2D) (for dose expansion phase) 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. The selection of RP2D will be based on consideration of overall safety information together with available pharmacokinetic and efficacy data.

  Approximately 30 months

Secondary Outcomes (6)

• Plasma concentration of HDM2005, total antibody and the free MMAE

  up to 28 days following last dose

• Immunogenicity

  up to 28 days following last dose

• Objective Response Rate (ORR)(for dose escalation phase)

  Approximately 18 months

• Time to Response (TTR)

  Approximately 30 months

• Duration of Response (DOR)

  Approximately 30 months

Study Arms (1)

HDM2005

EXPERIMENTAL

In dose escalation phase, participants will be administered escalating doses of HDM2005 at 1.8\~2.5mg/kg IV on Day 1 of repeated 21-day cycles or 1.2\~2.0mg/kg IV on Day 1 of repeated 14-day cycles . In dose expansion phase, participants will be administered to recommended dose for expansion (RDE) of HDM2005 .

Drug: HDM2005

Interventions

HDM2005 DRUG

HDM2005 will be administered via IV infusion.

HDM2005

Eligibility Criteria

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

You may qualify if:

• 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;
• ECOG performance status of 0-1.
• Life expectancy of at least 3 months.
• Specific types of advanced solid tumors that have been confirmed by histopathological examination.
• Has metastatic disease that has progressed during or following previous treatment appropriate for the disease type.
• All subjects are required to provide archived tissue (5 unstained sections) obtained within the previous 2 years or fresh tissue for ROR1 expression testing at the central laboratory.
• Presence of radiographically measurable disease.
• Subjects must have recovered (to ≤ Grade 1) from any AE associated with prior anticancer therapy.
• Has adequate organ function.
• Female subjects of childbearing potential should agree to use contraception methods during the study and for 6 months after the end of the study; have a negative serum pregnancy test within 7 days before study enrollment; and male subjects should agree to use contraceptive avoidance measures during the study and for 6 months after the end of the study.

You may not qualify if:

• Patients with active brain metastases (defined as stable for \< 4 weeks, or symptomatic, or requiring antiepileptic drug/hormonal therapy, or meningeal metastases).
• 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.
• History of severe bleeding disorders .
• History of chronic pancreatitis or acute pancreatitis within 6 months.
• History of interstitial lung disease, radiation pneumonitis requiring steroid therapy, or any evidence of clinically active interstitial lung disease.
• Patients with uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage after intubation and drainage,VEGF inhibitors, platinum and other drugs injection (subjects with stable symptoms for at least one week after treatment can be enrolled).
• Prior solid organ transplantation.
• Has peripheral neuropathy of Grade \>1.
• Has significant cardiovascular or cerebrovascular diseases.
• Has an uncontrolled ongoing infection.
• Active infectious disease, such as HIV infection, active hepatitis B, active hepatitis C (positive RNA result), active syphilis.
• Receiving corticosteroids (prednisone equivalent more than10 mg/day).
• Contraindication to any component of HDM2005.
• History of drug anaphylactic shock, severe food allergy, uncontrolled asthma or COPD.
• Female subjects who are pregnant, lactating or planning to become pregnant during the study.

Sponsors & Collaborators

• Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Fudan University shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Central Study Contacts

Jun Zhou

CONTACT

18061872796; hdgdzhoujun@eastchinapharm.com

Study Design

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

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 4, 2025
• Study Start: May 29, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 8, 2025

Record last verified: 2025-05

Locations

CN (1)