A Study of Tucatinib and Trastuzumab in People With Rectal Cancer

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT05672524
Phase
PHASE2
Status
Recruiting
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Conditions

  • Adenocarcinoma of the Rectum
  • HER2 Positive Rectal Adenocarcinoma
  • Locally Advanced Rectal Adenocarcinoma
  • Rectal Adenocarcinoma
  • Rectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab — DRUG
    Patients will then be given tucatinib (300 mg BID orally) and trastuzumab (8 mg/kg on day 1, then 6 mg/kg starting cycle 2 and every three weeks) therapy for an initial 6 week lead-in period. All patients, regardless of findings on rectal MRI will then transition to standard of care induction chemotherapy with continuation of the trastuzumab and tucatinib for a total of five additional cycles (15 extra weeks).
  • Tucatinib — DRUG
    Patients will then be given tucatinib (300 mg BID orally) and trastuzumab (8 mg/kg on day 1, then 6 mg/kg starting cycle 2 and every three weeks) therapy for an initial 6 week lead-in period. All patients, regardless of findings on rectal MRI will then transition to standard of care induction chemotherapy with continuation of the trastuzumab and tucatinib for a total of five additional cycles (15 extra weeks).

Study Details

The study researchers believe that a combination of the drugs trastuzumab and tucatinib, given with standard chemotherapy (capecitabine and oxaliplatin/FOLFOX), may help participants with rectal cancer.

Key Dates

Start date
Dec 30, 2022
Status verified
May 2026
Primary completion
Jul 30, 2027
Completion
Jul 31, 2030

Study Design

Enrollment
37 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Participant with Rectal Adenocarcinoma
    Participants will have HER2-positive locally advanced rectal adenocarcinoma.

Primary Outcome Measure

Clinical complete response of study participants [ Time Frame: 21 +/- 4 weeks ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Andrea Cercek, MD
646-888-4189
Andrea Cercek, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Andrea Cercek, MD
646-888-4189
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Andrea Cercek, MD
646-888-4189
Memorial Sloan Kettering Cancer Center at Suffolk - Commack (Limited Protocol Activities)CommackNew York11725
Andrea Cercek, MD
646-888-4189
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Andrea Cercek, MD
646-888-4189
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Andrew Cercek, MD
646-888-4189
Memorial Sloan Kettering Nassau (Limited Protocol Activities)UniondaleNew York11553
Andrea Cercek, MD
646-888-4189

Find similar trials in Basking Ridge, NJ

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Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Cancer Center at Suffolk - Commack (Limited Protocol Activities)· Commack, NYMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY

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