Clinical trial NCT05712889: Phase 1 Dose Escalation Study for VIP236 in Patients With Advanced Cancer
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Keywords: VIP236
Solid tumors
Biliary tract cancer
Breast cancer
Small cell lung cancer
Triple negative breast cancer
Cervical cancer
Gastric cancer
Lung cancer
Non-small cell lung cancer
Ovarian cancer
Pancreatic adenocarcinoma
Advanced solid tumors
Metastatic cancer
Endometrial cancer
Urothelial cancer
Lead sponsor: Vincerx Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2023-02-06
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of DLT (Dose limit toxicity) of VIP236
timeFrame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days
measure: Number of participants with adverse events as a measure safety and tolerability
timeFrame: 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:
measure: 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
timeFrame: Up to 24 onths
measure: 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.
timeFrame: 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)
measure: 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
timeFrame: Up to 24 months
measure: Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of VIP236
timeFrame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days
measure: Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of VIP236
timeFrame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Honor Health
state: Arizona
city: Austin
country: United States
facility: NEXT Austin
state: Texas
city: San Antonio
country: United States
facility: NEXT Oncology San Antonio
state: Texas
city: Macquarie Park
country: Australia
facility: Macquarie University
state: New South Wales
city: Brisbane
country: Australia
facility: ICON Brisbane
state: Queensland
city: Adelaide
country: Australia
facility: ICON Adelaide
state: Southern Australia
Study officials:
affiliation: Vincerx Pharma, Inc.
name: Vincerx Study Director
role: STUDY_DIRECTOR
References: