A Study to Evaluate the Safety and Activity of GDC-7035 With Anti-Cancer Therapies in Participants With KRAS G12D-Mutated Unresectable Advanced or Metastatic Colorectal Cancer or Pancreatic Ductal Adenocarcinoma
A Phase Ib, Multicenter, Randomized Study Evaluating the Safety and Activity of GDC-7035 With Anti-Cancer Therapies as First-Line Treatment in Patients With KRAS G12D-Mutated Unresectable Advanced or Metastatic Colorectal Cancer or Pancreatic Ductal Adenocarcinoma
The primary purpose of this study is to evaluate the safety of GDC-7035 as a single agent and in combination with other anti-cancer therapies in participants with KRAS G12D-mutated metastatic colorectal cancer (CRC) or pancreatic ductal adenocarcinoma (PDAC). The study consists of a safety run-in period followed by a randomized/expansion period.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 1
Kontakter og plasseringer
Studiekontakt
- Navn: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Studer Kontakt Backup
- Navn: Reference Study ID Number: GO46205 https://forpatients.roche.com/ No attachments to email below.
- Telefonnummer: 888-662-6728 (U.S. Only)
- E-post: global-roche-genentech-trials@gene.com
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Confirmed presence of the Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D mutation as documented through central laboratory testing or prior local laboratory testing
- Agreement to adhere to the contraception requirements described in the protocol for participants of childbearing potential and participants who produce sperm
Exclusion Criteria:
- Malabsorption syndrome or other conditions that would interfere with enteral absorption
- Known and untreated, or active central nervous system (CNS) metastases
- Known clinically significant liver disease
- History of or active clinically significant cardiovascular dysfunction
Other protocol-defined inclusion/exclusion criteria may apply.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Group A: GDC-7035 + mFOLFOX6 + Panitumumab
Participants with CRC will receive GDC-7035 in combination with modified (levo)leucovorin, 5-fluorouracil (5-FU), oxaliplatin (mFOLFOX6) and panitumumab as per the schedule specified in the protocol during the safety run-in period. Participants in the randomized or expansion period will also receive GDC-7035 in combination with mFOLFOX6 and panitumumab at doses determined to be safe in the safety run-in period. |
Participants will receive GDC-7035 as per the schedule specified in the protocol.
Andre navn:
Participants will receive panitumumab in accordance with the local prescribing information. Participants will receive mFOLFOX6 in accordance with the local prescribing information. |
|
Eksperimentell: Group B: GDC-7035 + FOLFIRI + Panitumumab
Participants with CRC will receive GDC-7035 in combination with leucovorin, 5-FU, irinotecan (FOLFIRI), and panitumumab as per the schedule specified in the protocol during the safety run-in period. Participants in the randomized or expansion period will also receive GDC-7035 in combination with FOLFIRI and panitumumab at doses determined to be safe in the safety run-in period. |
Participants will receive GDC-7035 as per the schedule specified in the protocol.
Andre navn:
Participants will receive panitumumab in accordance with the local prescribing information. Participants will receive FOLFIRI in accordance with the local prescribing information. |
|
Eksperimentell: Group C: GDC-7035 + mFOLFIRINOX or GDC-7035 Monotherapy
Participants with PDAC will receive GDC-7035 in combination with modified leucovorin, 5-FU, irinotecan, oxaliplatin (mFOLFIRINOX) as per the schedule specified in the protocol during the safety run-in period. Participants in the randomized or expansion period will also receive GDC-7035 as a single agent or in combination with mFOLFIRINOX at doses determined to be safe in the safety run-in period. |
Participants will receive GDC-7035 as per the schedule specified in the protocol.
Andre navn:
Participants will receive mFOLFIRINOX in accordance with the local prescribing information. |
|
Eksperimentell: Group D: GDC-7035 + Gem-nabP or GDC-7035 Monotherapy
Participants with PDAC will receive GDC-7035 in combination with gemcitabine and nab-paclitaxel (Gem-nabP) as per the schedule specified in the protocol during the safety run-in period. Participants in the randomized or expansion period will also receive GDC-7035 as a single agent or in combination with Gem-nabP at doses determined to be safe in the safety run-in period. |
Participants will receive GDC-7035 as per the schedule specified in the protocol.
Andre navn:
Participants will receive Gem-nabP in accordance with the local prescribing information. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Number of Participants With Adverse Events (AEs)
Tidsramme: Up to approximately 30 months
|
Up to approximately 30 months
|
|
Number of Participants With Key Treatment-Emergent Adverse Events (TEAEs)
Tidsramme: Up to Day 28
|
Up to Day 28
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Varighet av respons (DOR)
Tidsramme: Opptil ca 30 måneder
|
Opptil ca 30 måneder
|
|
Objektiv svarprosent (ORR)
Tidsramme: Opptil omtrent 30 måneder
|
Opptil omtrent 30 måneder
|
|
Progression-free Survival (PFS) After Randomization
Tidsramme: Up to approximately 30 months
|
Up to approximately 30 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Clinical Trials, Hoffmann-La Roche
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter nettsted
- Neoplasmer
- Tarmsykdommer
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Sykdommer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Intestinale neoplasmer
- Rektale sykdommer
- Kolonsykdommer
- Kolorektale neoplasmer
- Aminosyrer, peptider og proteiner
- Proteiner
- Antistoffer, monoklonalt, humanisert
- Antistoffer, monoklonalt
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serumglobuliner
- Globuliner
- Panitumumab
- IFL -protokoll
Andre studie-ID-numre
- GO46205
- 2026-525460-17-00 (Ctis)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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