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Tests treatment safety and results for Neoplasms
Official title A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Clinical Activity of RO7673396 in Participants With Advanced Solid Tumors Harboring Rat Sarcoma Viral Oncogene Homolog (RAS) Mutation(s)
ClinicalTrials.gov ID: NCT06884618
What this study is testing
What is RO7673396?
RO7673396 is an investigational medicine, being studied as a potential treatment for neoplasms.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to evaluate the safety and tolerability of RO7673396 in participants with advanced solid tumors harboring RAS mutation(s). This study consists of two stages: Stage 1 (Dose Escalation) and Stage 2 (Dose Expansion).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically documented, locally advanced, recurrent, or metastatic incurable solid tumors
- Participants with measurable disease according to RECIST v1.1 assessed by the investigator
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy ≥12 weeks
- Adequate hematologic and end-organ function
You likely can't join if
- Current participant or enrollment in another treatment clinical trial
- Known hypersensitivity or medical contraindication to any component of RO7673396 formulation
- Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate study...
- Known and untreated, or active central nervous system (CNS) metastases
- Participants with chronic diarrhea, short bowel syndrome or significant upper gastrointestinal (GI) surgery including gastric resection, a history of...
- Treatment with chemotherapy, immunotherapy, biologic therapy, or an investigational agent as anti-cancer therapy within 4 weeks or five half-lives...
See the full eligibility criteria
- Histologically documented, locally advanced, recurrent, or metastatic incurable solid tumors
- Participants with measurable disease according to RECIST v1.1 assessed by the investigator
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy ≥12 weeks
- Adequate hematologic and end-organ function
- Confirmed presence of the RAS mutation(s)
- Current participant or enrollment in another treatment clinical trial
- Known hypersensitivity or medical contraindication to any component of RO7673396 formulation
- Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate study treatment absorption
- Known and untreated, or active central nervous system (CNS) metastases
- Participants with chronic diarrhea, short bowel syndrome or significant upper gastrointestinal (GI) surgery including gastric resection, a history of inflammatory bowel disease (IBD)
- Treatment with chemotherapy, immunotherapy, biologic therapy, or an investigational agent as anti-cancer therapy within 4 weeks or five half-lives prior to initiation of study treatment
- Participants who are on acid-reducing agents and unable to safely discontinue them as required in the study
- Major surgical procedure within 28 days prior to initiation of study treatment, or incomplete recovery from surgery that would interfere with the determination of safety or how well it works of study treatment, or...
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- Known clinically significant liver disease
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Sarasota, Florida, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Darlinghurst, New South Wales, Australia
- Parkville, Victoria, Australia
- Toronto, Ontario, Canada
- Guangzhou, Guangdong, China
- Guangzhou, China
- Shanghai, China
- Wuhan, China
- København Ø, Denmark
- Hong Kong, Hong Kong
- Auckland, New Zealand
- Christchurch, New Zealand
- Singapore, Singapore
- Pamplona, Navarre, Spain
- Tainan, Taiwan
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Aurora, Colorado, United States; New Haven, Connecticut, United States; Sarasota, Florida, United States; Houston, Texas, United States; San Antonio, Texas, United States and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.