Evaluating a new treatment for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human study aims to assess the safety and tolerability of VVD-159642, a novel RAS-PI3Kα inhibitor, in patients with advanced solid tumors. The study will evaluate the pharmacokinetics and pharmacodynamics of VVD-159642 both as a standalone treatment and in combination with other therapies like sotorasib or trametinib. Participants will be closely monitored for any adverse effects and preliminary anti-tumor activity will also be assessed. The trial focuses on patients with specific types of solid tumors that have certain genetic alterations.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* For Part 1 Dose Escalation, the prospective participant must have histologically confirmed pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), or any solid tumor that harbors a rat sarcoma viral oncogene (RAS) alteration \[Kirsten rat sarcoma viral oncogene homolog (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), Harvey rat sarcoma viral oncogene homolog (HRAS)\] as per local /historical testing; any solid tumor that harbors an epidermal growth factor receptor (EGFR) alteration as per local/historical testing; or human epidermal growth factor receptor 2 (HER2) overexpression (immunohistochemistry \[IHC\] 3+ or IHC 2+/fluorescence in situ hybridization \[FISH\] positive) as per local/historical testing.
* Have histologically or cytologically confirmed metastatic or unresectable solid tumors.
* Measurable disease by RECIST version 1.1 as assessed by the investigator.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
* Adequate bone marrow, kidney, and liver function as defined in the protocol.
* Able to take oral medications.

Key Exclusion Criteria:

* Active central nervous system (CNS) malignancies.
* History of cardiac diseases as defined in detail in the protocol.
* Uncontrolled arterial hypertension despite optimal medical management (per investigator's opinion).
* History of inflammatory bowel disease or any malabsorption syndrome or any conditions that would interfere with enteral absorption and/or may interfere with the conduct of the study.
* Active hepatitis B infection \[positive for hepatitis B surface antigen and Hepatitis B virus deoxyribonucleic acid (DNA)\].
* Active hepatitis C infection (positive anti-hepatitis C virus \[HCV\] antibody and quantitative HCV ribonucleic acid (RNA) results greater than the lower limits of detection of the assay).

Where it's running

• START Mid West
  Grand Rapids, Michigan, United States Recruiting
• NEXT Austin
  Austin, Texas, United States Recruiting
• NEXT Dallas
  Irving, Texas, United States Recruiting
• START San Antonio
  San Antonio, Texas, United States Recruiting
• NEXT San Antonio
  San Antonio, Texas, United States Recruiting
• START Mountain
  Ogden, Utah, United States Recruiting

Study contacts

• Study coordinator: Vividion Clinical Trial Call Center
• Email: clinicaltrials@vividion.com
• Phone: 858-345-9752

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CG-7321: a first-in-human test in advanced solid tumors

  We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.

  Recruiting at 4 sites Phase 1 Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd. · Fuzhou, Fujian and 3 other locations · NCT07923214

• AK157D1 injection for advanced solid tumors

  A first-in-human Phase 1 study tests AK157D1 injection in adults with unresectable advanced solid tumors to see if it is safe and tolerable and to get early signs of how it behaves in the body and against tumors.

  Recruiting Phase 1 Akeso · Harbin, Heilongjiang and 2 other locations · NCT07847281

• ABBV-253 in adults with advanced solid tumors

  This study tests ABBV-253 to see if it is safe, how it affects the cancer, and how the drug moves in the body for adults with advanced solid tumors.

  Recruiting at 3 sites Phase 1 AbbVie · Grand Rapids, Michigan and 2 other locations · NCT07807956

• MK-2010 alone or with other treatments for advanced solid tumors

  This trial tests MK-2010, by itself or with other cancer medicines, to see if it helps people with advanced solid tumors.

  Recruiting at 7 sites Phase 2 Merck Sharp & Dohme LLC · Belleville, New Jersey and 6 other locations · NCT07793942

• Whole-Body Infrared Heating for Advanced Solid Tumors

  This study looks at how ET-SPACE whole-body infrared hyperthermia affects people with advanced solid tumors to see if it changes biology, symptoms, and safety.

  Recruiting Zhejiang Hospital · Hangzhou, Zhejiang · NCT07793214

• MK-2010 with Sac-TMT in advanced solid tumors

  This study tests MK-2010 combined with sacituzumab tirumotecan (sac-TMT) to see if it can help people with advanced solid tumors.

  Recruiting at 4 sites Phase 2 Merck Sharp & Dohme LLC · San Antonio, Texas and 3 other locations · NCT07785609

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.