AMT-151 in Patients With Selected Advanced Solid Tumours

NCT05498597 | Unknown Phase 1

• 1 other identifier: AMT-151-01
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 9

Brief 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.

Conditions

Advanced Solid Tumor; Advanced Cancer; Advanced Carcinoma; Ovarian Cancer; Ovarian Carcinoma; Ovarian Epithelial Cancer; Ovarian Endometrioid Adenocarcinoma; Endometrial Cancer; Endometrial Adenocarcinoma; Endometrial Serous Adenocarcinoma; Endometrial Endometrioid Adenocarcinoma; Endometrial Clear Cell Adenocarcinoma; Lung Adenocarcinoma; Triple Negative Breast Cancer; Pancreatic Ductal Adenocarcinoma; Malignant Pleural Mesothelioma; Ovarian Clear Cell Carcinoma; Ovarian Clear Cell Adenocarcinoma; Ovarian Mucinous Adenocarcinoma

Keywords

Carcinoma; Cancer; Antibody-Drug Conjugate; Folate Receptor Alpha

Outcome Measures

Primary Outcomes (3)

• Recommended Phase 2 Dose (RP2D)

  The RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data

  Up to 24 months

• Maximum Tolerated Dose (MTD)

  The MTD will be determined using DLTs

  Up to 24 months

• Incidence of Adverse Events

  Safety and tolerability profile assessed by the Common Terminology Criteria for Adverse Events v5.0

  Up to 24 months

Secondary Outcomes (11)

• Overall Response Rate (ORR) according to the Response Evaluation Criteria in Solid Tumours (RECIST) v1.1

  Up to 24 months

• Disease Control Rate (DCR) according to the RECIST v1.1

  Up to 24 months

• Progression-free Survival (PFS)

  Up to 24 months

• Time to Treatment Response (TTR)

  Up to 24 months

• Duration of Response (DoR)

  Up to 24 months

Study Arms (1)

AMT-151 Dose Escalation

EXPERIMENTAL

Drug: AMT-151

Interventions

AMT-151 DRUG

Administered intravenously

AMT-151 Dose Escalation

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Prior treatment with any agent targeting Folate Receptor Alpha.
• Active central nervous system metastasis.
• Persistent toxicities from previous systemic anti-neoplastic treatments of Grade \>1.
• Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to the first dose of the study drug.
• Radiotherapy to lung field at a total radiation dose of \>= 20 Gy within 6 months, wide-field radiotherapy (\>30% of marrow-bearing bones) within 28 days, or focal radiation for analgesic purpose or for lytic lesions at risk of fracture within 14 days prior to the first dose of the study drug, or no recovery from side effects of such intervention.
• Major surgery (not including placement of vascular access device or tumor biopsies) within 28 days prior to the first dose of the study drug, or no recovery from side effects of such intervention.
• Prior allogeneic or autologous bone marrow transplantation.
• Significant cardiac or lung disease, active or chronic ocular disorders, thromboembolic or cerebrovascular events within 6 months prior to the first dose of the study drug, acute and/or clinically significant bacterial, fungal, or viral infection.
• Pregnant or breast-feeding females.

Sponsors & Collaborators

• Multitude Therapeutics Inc.: lead
• Tigermed Consulting Co., Ltd: collaborator

Study Sites (9)

Chris O'Brien Lifehouse

Sydney, New South Wales, Australia

RECRUITING

ICON Cancer Centre

Brisbane, Queensland, Australia

RECRUITING

Mater Cancer Care Centre

South Brisbane, Queensland, Australia

RECRUITING

Cancer Research SA

Adelaide, South Australia, Australia

RECRUITING

Cabrini Malvern Hospital

Malvern, Victoria, Australia

RECRUITING

One Clinical Research (OCR)

Perth, Western Australia, Australia

RECRUITING

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, 350014, China

NOT YET RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410031, China

NOT YET RECRUITING

Shanghai Tumor Hospital

Shanghai, Shanghai Municipality, 200032, China

NOT YET RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Endometrial Neoplasms; Adenocarcinoma of Lung; Triple Negative Breast Neoplasms; Mesothelioma, Malignant; Carcinoma; Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Uterine Neoplasms; Uterine Diseases; Adenocarcinoma; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Breast Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Mesothelioma; Adenoma; Neoplasms, Mesothelial; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Sarwan Bishnoi

  Cancer Research SA

  PRINCIPAL INVESTIGATOR

• Richardson Gary

  Cabrini Malvern Hospital

  PRINCIPAL INVESTIGATOR

• Steven Kao

  Chris O'Brien Lifehouse

  PRINCIPAL INVESTIGATOR

• Catherine Shannon

  Mater Cancer Care Centre

  PRINCIPAL INVESTIGATOR

• Jermaine Coward

  ICON Cancer Centre

  PRINCIPAL INVESTIGATOR

• Mihitha Ariyapperuma

  One Clinical Research (OCR)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jane Zhu

CONTACT

13917933915; juanjuan.zhu@multitudetherapeutics.com

Study Design

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

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 12, 2022
• Study Start: January 25, 2023
• Primary Completion: January 1, 2024
• Study Completion: October 30, 2024
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (6); CN (3)