A Dose Escalation/Expansion Study Of MDK-703 In Patients With Advanced Or Metastatic Solid Tumors

Study Overview

A Dose Escalation/Expansion Study of MDK-703 in Patients With Advanced or Metastatic Solid Tumors

This is an open-label, dose escalation and dose expansion study of MDK-703 as a monotherapy and in combination with other cancer therapies in adult study participants with advanced or metastatic solid tumors.

This is a Phase 1/2, open-label, multicenter, dose escalation and dose expansion study evaluating MDK-703 in adult study participants with advanced or metastatic solid tumors. This study will initially commence with dose escalation to evaluate the safety/tolerability of MDK-703 as a monotherapy and in combination with other cancer therapies. Once the monotherapy and/or combination therapy maximum tolerated dose (MTD), optimal biological dose (OBD), and/or recommended dose (RD) has been determined, then dose expansion of MDK-703 may commence in select populations of interest. The study will also evaluate the anti-tumor activity and pharmacokinetic (PK) and pharmacodynamic (PD) profiles of MDK-703 as a monotherapy and in combination with other cancer therapies.

Advanced or Metastatic Solid Tumors

DRUG: MDK-703
DRUG: Checkpoint Inhibitor, Immune

MDK-703-102

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-01-19	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-05-06
First Submitted that Met QC Criteria 2023-02-06	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-05-08
First Posted (ACTUAL) 2023-02-08	Results First Posted N/A	Last Verified 2024-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: MDK-703 Monotherapy MDK-703 will be administered in sequential ascending doses as a monotherapy until unacceptable toxicity, disease progression, or withdrawal of consent.	DRUG: MDK-703 MDK-703 will be administered as specified under Arm description.
EXPERIMENTAL: MDK-703 in combination with a checkpoint inhibitor MDK-703 will be administered in sequential ascending doses in combination with a checkpoint inhibitor until unacceptable toxicity, disease progression, or withdrawal of consent.	DRUG: MDK-703 MDK-703 will be administered as specified under Arm description. DRUG: Checkpoint Inhibitor, Immune Checkpoint inhibitor will be administered as specified under Arm description.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: MDK-703 Monotherapy

MDK-703 will be administered in sequential ascending doses as a monotherapy until unacceptable toxicity, disease progression, or withdrawal of consent.

DRUG: MDK-703

MDK-703 will be administered as specified under Arm description.

EXPERIMENTAL: MDK-703 in combination with a checkpoint inhibitor

MDK-703 will be administered in sequential ascending doses in combination with a checkpoint inhibitor until unacceptable toxicity, disease progression, or withdrawal of consent.

DRUG: MDK-703

MDK-703 will be administered as specified under Arm description.

DRUG: Checkpoint Inhibitor, Immune

Checkpoint inhibitor will be administered as specified under Arm description.

Primary Outcome Measures	Measure Description	Time Frame
Dose Limiting Toxicities (DLT)	Based on toxicities observed from time of first dose through first cycle of treatment	Assessed up to 24 months
Maximum tolerated dose (MTD)	Based on toxicities observed	Assessed up to 24 months
Optimal biological dose (OBD)	Based on toxicities observed	Assessed up to 24 months
Recommended dose (RD)	Based on toxicities observed	Assessed up to 24 months
Adverse events (AE)	Incidence and severity of treatment-emergent AEs and serious AEs as assessed by CTCAE v5.0	Assessed up to 24 months

Secondary Outcome Measures	Measure Description	Time Frame
Objective Response Rate (ORR)	Based on assessment of radiographic imaging per RECIST version 1.1	Assessed up to 24 months
Duration of Response (DOR)	Based on assessment of radiographic imaging per RECIST version 1.1	Assessed up to 24 months
Time to Response (TTR)	Based on assessment of radiographic imaging per RECIST version 1.1	Assessed up to 24 months
Disease Control Rate (DCR)	Based on assessment of radiographic imaging per RECIST version 1.1	Assessed up to 24 months
Progression-Free Survival (PFS)	Based on assessment of radiographic imaging per RECIST version 1.1	Assessed up to 24 months
Overall Survival (OS)	Based on assessment of radiographic imaging per RECIST version 1.1	Assessed up to 24 months
Blood concentration of MDK-703	Blood concentration of MDK-703 at various timepoints	Assessed up to 24 months
Time to achieve maximum blood concentration	Time to achieve maximum blood concentration of MDK-703	Assessed up to 24 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Measurable disease per RECIST v1.1.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate cardiovascular, hematological, liver, and renal function.
Prior anti-cancer therapy is allowed as long as any treatment related toxicity is resolved to an appropriate level.
Females of childbearing potential and men who are not surgically sterile must agree to use medically-accepted method of birth control during the study.
[Females] Negative serum pregnancy test within 14 days prior to initiating study treatment.
[Males] Agreement to refrain from donating or banking sperm during the treatment period.

Treated with anti-cancer therapy or an investigational agent within 2 weeks or 5 half-lives prior to first dose, whichever is shorter; or within 4 weeks for immunotherapy.
Unresolved toxicities from prior systemic therapy greater than NCI CTCAE grade 1 at time of first dose, except alopecia, vitiligo, and grade 2 neuropathy due to prior chemotherapy.
Radiotherapy within 14 days prior to first dose of study drug.
Major surgery within 30 days prior to first dose of study drug, or anticipation of major surgery during study treatment.
Active autoimmune disease requiring systemic treatment within the past 3 months or have a documented history of clinically severe autoimmune disease that requires systemic steroids or immunosuppressive agents.
Primary central nervous system (CNS) disease or leptomeningeal disease.
Impaired cardiovascular function or clinically significant cardiovascular disease.
Uncontrolled diabetes mellitus or other uncontrolled immune-related endocrinopathies.
Abnormal pulmonary function within the previous 6 months, including history of pneumonitis, active pneumonitis, interstitial lung disease requiring the use of steroids, idiopathic pulmonary fibrosis, active pleural effusion, severe dyspnea at rest or requiring supplementary oxygen therapy.
History of allogenic, bone marrow, or solid organ transplant.
History of cerebrovascular events within 6 months prior to first dose.
Human immunodeficiency virus (HIV) infection or active infection with hepatitis C; uncontrolled hepatitis B infection.
Clinically significant bleeding within 2 weeks prior to first dose (e.g., gastrointestinal bleeding, intracranial hemorrhage).
Prior diagnosis of pulmonary embolism within 3 months prior to first dose.
Known intolerance, hypersensitivity, or contraindication to any components of MDK-703 or checkpoint inhibitors for applicable cohorts.
History of other malignancy within 5 years prior to first dose, except for patients who are disease-free for >2 years after treatment with curative intent or who have carcinoma in situ which has been excised.
Any serious medical condition (including pre-existing autoimmune disease or inflammatory disorder), laboratory abnormality, psychiatric condition, or any other significant or unstable concurrent medical illness that in the opinion of the Investigator would preclude protocol therapy or would make the subject inappropriate for the study.
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Joseph Leveque, MD, Chief Medical Officer

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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