First-in-Human, Phase 1 Study of AMT-151, an Anti-Folate Receptor Alpha Antibody-Drug Conjugate, in Patients With Selected Advanced Solid Tumours

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This first-in-human study will evaluate the Maximum Tolerated Dose (MTD) / the Recommended Phase 2 Dose (RP2D), safety, tolerability, anti-tumor activity, pharmacokinetics, pharmacodynamics and immunogenicity of AMT-151, a novel antibody-drug conjugate against folate receptor alpha, in patients with selected advanced solid tumors.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients must be willing and able to sign the Informed Consent Form, and to adhere to the study visit schedule and other protocol requirements.

• Age ≥18 years (at the time consent is obtained).

• Patients with the following histologically confirmed, advanced cancer diagnoses:

‣ Serous, endometrioid, clear-cell, or mucinous epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

⁃ Serous, endometrioid, or clear-cell endometrial cancer.

⁃ Adenocarcinoma of the lung.

⁃ Triple-negative breast cancer.

⁃ Pancreatic ductal adenocarcinoma.

⁃ Malignant pleural mesothelioma.

• Patients who have undergone any number of prior systemic therapies and have radiologically or clinically determined progressive disease during or after their most recent line of therapy, and for whom no further standard therapy is available, or who are intolerable to standard therapy.

• Patients must have at least one measurable or non-measurable lesion as per RECIST version 1.1.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Adequate function of bone marrow, liver, kidneys, heart.

• Both male and female patients must agree to use effective contraceptive methods.

• Women of child-bearing potential (WCBP) must have a negative serum pregnancy test.

• Availability of tumour tissue sample (either an archival specimen or a fresh biopsy material) at screening.

Locations
Other Locations
Australia
Cancer Research SA
RECRUITING
Adelaide
ICON Cancer Centre
RECRUITING
Brisbane
Cabrini Malvern Hospital
RECRUITING
Malvern
One Clinical Research (OCR)
RECRUITING
Perth
Mater Cancer Care Centre
RECRUITING
South Brisbane
Chris O'Brien Lifehouse
RECRUITING
Sydney
China
Hunan Cancer Hospital
NOT_YET_RECRUITING
Changsha
Fujian Provincial Cancer Hospital
NOT_YET_RECRUITING
Fuzhou
Shanghai Tumor Hospital
NOT_YET_RECRUITING
Shanghai
Contact Information
Primary
Jane Zhu
juanjuan.zhu@multitudetherapeutics.com
13917933915
Time Frame
Start Date: 2023-01-25
Estimated Completion Date: 2024-10-30
Participants
Target number of participants: 30
Treatments
Experimental: AMT-151 Dose Escalation
Sponsors
Leads: Multitude Therapeutics Inc.
Collaborators: Tigermed Consulting Co., Ltd

This content was sourced from clinicaltrials.gov