NCT05712889CompletedPhase 1
Phase 1 Dose Escalation Study for VIP236 in Patients With Advanced Cancer
An Open-label, Multicenter Phase 1 Study to Characterize Safety, Tolerability, Preliminary Antitumor Activity and Pharmacokinetics of VIP236 Monotherapy in Subjects With Advanced Cancer
Source: ClinicalTrials.gov · Last updated 15 Nov 2024
Brief summary (registry, in English)
Determine the safety, tolerability, and maximum tolerated dose (MTD) of IV administered VIP236 as monotherapy in patients with advanced solid tumor cancer
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 29 (actual)
- First submitted
- 25 Jan 2023
- Start date
- 24 Jan 2023
- Primary completion date
- 10 Oct 2024
- Lead sponsor
- Vincerx Pharma, Inc.
- Diseases
- Triple-negative breast cancer, Endometrial cancer, Cervical cancer, Lung cancer, Pancreatic cancer, Liver and biliary tract cancer, Gastric and esophageal cancer, Ovarian cancer
- NCT number
- NCT05712889
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 29
- From 24 Jan 2023 to the primary completion date, 10 Oct 2024
- 6 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Medical history of chronic obstructive pulmonary disease (COPD) and other respiratory disorders.
Other
- Subjects who have new or progressive brain or meningeal or spinal metastases.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ICON Adelaide Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| ICON Brisbane Coordinator of this site? Confirm its status | Brisbane | Australia | Unknown status |
| Macquarie University Coordinator of this site? Confirm its status | Macquarie Park | Australia | Unknown status |
| NEXT Austin Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| NEXT Oncology San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Honor Health Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.