A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of KD033 (SAR445710) in Subjects With Metastatic or Locally Advanced Solid Tumors

NCT04242147 | Terminated Phase 1 FDA Drug

• 4 other identifiers: TED17644KD033-101U1111-1279-24062022-503080-15
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 5

Brief Summary

This is a Phase1, open-label, sequential dose-escalation and dose-expansion study of KD033 (SAR445710) in adult participants with advanced or metastatic solid tumors. The main purpose of this study is to test KD033 (SAR445710) at different dose levels to see if it is safe and well tolerated when given once every 2 weeks and when given weekly. Additional purposes of the study are to find out whether the study drug has anti-cancer effects and how the study drug is processed by the body.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Occurrence of Dose Limiting Toxicities (DLTs)

  To evaluate the number of participants who experienced DLTs during the dose escalation phase

  Up to 28 days

• Treatment Emergent Adverse Events (TEAEs) and Treatment-related AEs by Severity

  To evaluate the number of TEAEs and treatment-related AEs by severity for all dose groups/cohorts according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)

  Up to 30 days after last treatment

Secondary Outcomes (5)

• Best Overall Response (BOR)

  Through study completion, an expected average of 1 year

• Duration Of Response (DOR)

  Through study completion, an expected average of 1 year

• Exploration of KD033 (SAR445710) Pharmacokinetic (PK) Profile - AUC

  Through study completion, an expected average of 1 year

• Exploration of KD033 (SAR445710) Pharmacokinetic (PK) Profile - Cmax

  Through study completion, an expected average of 1 year

• Exploration of Anti-KD033 (SAR445710) Antibodies

  Through study completion, an expected average of 1 year

Study Arms (3)

Bi-weekly Monotherapy Dose Escalation (Q2W)

EXPERIMENTAL

KD033 (SAR445710) will be administered in sequential ascending doses as a monotherapy via intravenous (IV) administration every 2 weeks (Q2W).

Drug: KD033 (SAR445710)

Weekly Monotherapy Dose Escalation (Q1W)

EXPERIMENTAL

KD033 (SAR445710) will be administered in sequential ascending doses as a monotherapy via intravenous (IV) administration once a week (QW) for 6 weeks and then every 2 week-dosing.

Drug: KD033 (SAR445710)

Dose Expansion

EXPERIMENTAL

KD033 (SAR445710) will be administered at recommended dose/schedule for expansion

Drug: KD033 (SAR445710)

Interventions

KD033 (SAR445710) DRUG

Pharmaceutical form: Solution for infusion Route of administration: intravenous (IV)

Bi-weekly Monotherapy Dose Escalation (Q2W); Dose Expansion; Weekly Monotherapy Dose Escalation (Q1W)

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed/documented advanced and/or metastatic solid tumor with at least one tumor lesion of location accessible to biopsy per clinical judgement of treating physician.
• Participants must be willing to provide a tumor biopsy at the following time points: Pre-treatment and at Cycle 4, Day 1. All other study eligibility criteria must be met before any biopsy sample is obtained.
• Measurable disease at baseline per RECIST v1.1 guidelines.
• Life expectancy of at least 3 months.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) score ≤ 1.
• Adequate organ and bone marrow functions.
• All toxicities related to prior radiotherapy, chemotherapy, or surgical procedure must have recovered to baseline or Grade ≤ 1 based on NCI-CTCAE v5.0 except alopecia (any grade), Grade 2 peripheral neuropathy and adverse events that are clinically non-significant or stable on supportive care.
• All participants, male and female, who are not surgically sterilized or postmenopausal must agree to use 'highly effective methods of contraception' during the study and for at least 60 days after the last dose of KD033 (SAR445710).
• Women of childbearing potential must have a negative pregnancy test within 7 days prior to KD033 (SAR445710) treatment.
• Ability to understand the purpose of the study, provide signed and dated informed consent from the participant/legal representative prior to performing any protocol-related procedures and able to comply with the study procedures and any locally required authorization.

You may not qualify if:

• Use of immunotherapy, biological therapy, cytokine therapy \< 21 days prior to the first dose of study drug.
• Use of immunomodulating agents \< 21 days prior to the first dose of study drug.
• Use of chemotherapy and approved tyrosine kinase inhibitor (TKI) therapy \< 14 days prior to the first dose of study drug.
• Anti PD-L1 or anti PD-1 therapy \< 6 weeks prior to the first dose of study drug.
• Radiotherapy within 14 days before the start of trial treatment (prior diagnostic biopsy is permitted), with the exception of palliative radiation as described: patients assigned to radiotherapy require at least 1 additional lesion that can be safely irradiated while sparing the index lesion(s), and for which radiation at the limited, palliative doses contemplated would be considered medically appropriate; The lesion should be causing some signs or symptoms (e.g., tumor-related pain), for which radiation is indicated per the physician's standard clinical practice.
• Use of any investigational drug or have major surgery within 28 days before the start of trial treatment
• Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required systemic immunosuppressive treatments.
• Systemic therapy with immunosuppressive agents including corticosteroids within 14 days before the start of trial treatment with the exception of corticosteroid replacement therapy for adrenal insufficiency
• Rapidly progressive disease which, in the opinion of Investigator, may predispose to inability to tolerate treatment or trial procedure.
• History or clinical evidence of central nervous system primary tumors or metastases including leptomeningeal metastases unless they have been previously treated, demonstrated no progression at least 1 months, are asymptomatic and have had no requirement for steroids or enzyme inducing anticonvulsants in the last 14 days before Screening - Participants with suspected brain metastases at Screening should undergo a CT/MRI of the brain prior to study entry.
• Receipt of any organ transplantation including hematopoietic cell transplantation.
• Has a paraneoplastic syndrome of autoimmune nature.
• History of interstitial lung disease or severe obstructive pulmonary disease.
• Clinically significant cardiovascular/cerebrovascular disease.
• QTc(F) interval \> 450 ms for men or \> 470 ms for women)

Sponsors & Collaborators

• Kadmon, a Sanofi Company: lead

Study Sites (5)

UCLA Hematology/Oncology, 2020 Santa Monica Boulevard, Suite 600 - Site 042

Santa Monica, California, 90404, United States

Location

Moffitt Cancer Center - Site 102

Tampa, Florida, 33612, United States

Location

Roswell Park Cancer Institute - 665 Elm St - Site 062

Buffalo, New York, 14263, United States

Location

Fox Chase Cancer Center - 333 Cottman Avenue - Site 141

Philadelphia, Pennsylvania, 19111, United States

Location

University of Pittsburgh Medical Center - Hillman Cancer Center - 5150 Centre Avenue, Suite 301 - Site 132

Pittsburgh, Pennsylvania, 15232, United States

Location

Related Links

• TED17644 Plain Language Results Summary

Study Design

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

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 27, 2020
• Study Start: March 6, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (5)