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Completed

NCT Number: NCT05712889

Phase 1 Dose Escalation Study for VIP236 in Patients With Advanced Cancer

Determine the safety, tolerability, and maximum tolerated dose (MTD) of IV administered VIP236 as monotherapy in patients with advanced solid tumor cancer

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Key information

Conditions

Neoplasms Adnexal Diseases Biliary Tract Diseases Biliary Tract Neoplasms Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Lung Diseases Lung Neoplasms Neoplasm Metastasis Neoplasms by Site Neoplastic Processes Ovarian Diseases Ovarian Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Small Cell Lung Carcinoma Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Triple Negative Breast Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Macquarie University, Macquarie Park, New South Wales, Australia

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About this study

Solid tumor subjects with histologically confirmed advanced or metastatic disease who have relapsed or refractory to standard of care. Subjects must have exhausted all available standard therapies or be deemed ineligible for potential available therapies.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients aged >/=18 years, able to provide informed consent and willing to comply with all study procedures.
  • Histologically confirmed advanced or metastatic solid tumors that are relapsed or refractory to standard of care. Subjects must have exhausted all available standard therapies or be deemed ineligible for potential available therapies. Refer to NCCN guidelines of each respective histology for guidance. Starting with Amendment 3, this study will focus enrollment on the following cancers:

Biliary tract cancers Breast cancer Cervical cancer Endometrial carcinoma Gastric cancer/gastroesophageal junction adenocarcinoma Nonsmall cell lung cancer Ovarian cancer/fallopian tube cancer/primary peritoneal cancer Pancreatic adenocarcinoma Small cell lung cancer Urothelial cancer

  • Adequate bone marrow, liver, and renal functions.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

Exclusion criteria

  • Subjects who have new or progressive brain or meningeal or spinal metastases.
  • Clinically significant cardiac disease including congestive heart failure > New York Heart Association (NYHA) Class II), evidence for coronary artery disease (eg, unstable angina (anginal symptoms at rest) or new-onset angina (within the last 6 months or myocardial infarction within the past 6 months before first dose.
  • Major surgery or significant trauma within 4 weeks before the first dose of study drug.
  • Medical history of chronic obstructive pulmonary disease (COPD) and other respiratory disorders.

Treatment and study plan

VIP236 (Q3W)

Drug

VIP236 will be administered by IV infusion once every 3 weeks, for a 21-day cycle.

VIP236 (Q2W)

Drug

VIP236 will be administered by IV infusion once every 2 weeks, for a 28-day cycle.

Primary outcomes

  1. Incidence of DLT (Dose limit toxicity) of VIP236

    Time frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days

  2. Number of participants with adverse events as a measure safety and tolerability

    Time frame: Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 28 days (up to approximately 10 months)

Secondary outcomes

  1. Objective response rate (ORR), defined as the proportions of subjects who have a best overall response of partial response (PR) or complete response (CR) as determined by investigators using RECIST 1.1

    Time frame: Up to 24 onths

  2. Disease control rate (DCR) per RECIST v1.1, defined as best overall response of complete response (CR), partial response (PR), or stable disease (SD) as determined by Investigator review.

    Time frame: Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 28 days (up to approximately 10 months)

  3. Progression-free survival per RECIST v1.1, defined as the time from enrollment to documented disease progression or death from any cause, whichever occurs earlier as determined by Investigator review

    Time frame: Up to 24 months

  4. Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of VIP236

    Time frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days

  5. Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of VIP236

    Time frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days

Sponsors and collaborators

Lead sponsor

Vincerx Pharma, Inc.

Industry

Registry information

Official study title

An Open-label, Multicenter Phase 1 Study to Characterize Safety, Tolerability, Preliminary Antitumor Activity and Pharmacokinetics of VIP236 Monotherapy in Subjects With Advanced Cancer

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 6, 2023
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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