A phase II study for HER2 amplified advanced solid tumors (JUPITER trial)

Phase 2

• Conditions: Solid tumors; HER2, solid tumor; D009369

• Registration Number: JPRN-jRCT2031180150
• Lead Sponsor: Ikeda Sadakatsu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-25
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

1. Patient with a histologically-proven locally advanced or metastatic biliary tract cancer, urothelial cancer, uterine cancer, ovarian cancer and other solid tumors except breast cancer, gastric cancer and colorectal cancer who is no longer benefitting from standard anti-cancer treatment or for whom, in the opinion of the investigator, no such treatment is available or indicated.
2. HER2 gene amplified tumor identified using next genome sequencing in a CLIA or CAP accredited laboratory.
3. Patient must have measurable or evaluable disease (per RECIST v1.1).
4. Able to provide tumor samples for genome sequencing (not apply if HER2 amplification was detected by FoundationOne CDx) .
5. 20 years of age or older
6. ECOG PS 0-1
7. Normal organ function as below
a. Hb >= 9.0g/dl
b. ANC >= 1,500/mm^3
c. PLT >= 75,000/mm^3
d. T-Bil < 2.0 mg/dL
e. AST and ALT < 2.5 X ULN
f. Serum Cre <= 1.5 mg/dL
8. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation, and for 28 weeks following completion of study therapy.
9. Written informed consent.

Exclusion Criteria

1. Ongoing toxicity > CTCAE grade 2, other than peripheral neuropathy, related to antitumor treatment that was completed within 4 weeks prior to registration. Patients with ongoing peripheral neuropathy of >= CTCAE grade 3 will be excluded.
2. Previous treatment with trastuzumab or pertuzumab for the same malignancy
3. If the patient's tumor has a genomic variant known to confer resistance to trasutuzumab or pertuzumab.
4. Patients with breast cancer harboring HER2 amplification/overexpression.
5. Patients with gastric cancer harboring HER2 amplification/overexpression.
6. Patients with colorectal cancer harboring HER2 amplification/overexpression.
7. Prior chemotherapy, immunotherapy or radiotherapy within 4 weeks of enrollment.
8. Primary brain tumor.
9. Patients with symptomatic uncontrolled brain metastases.
10. History of clinically significant cardiovascular disease.
11. Left Ventricular Ejection Fraction (LVEF) < 50%
12. History of stroke within 4 weeks of enrollment.
13. History of acute gastrointestinal bleeding within 4 weeks of enrollment.
14. Treatment with any investigational drug within 4 weeks of enrollment.
15. Patients with any other clinically significant medical condition.
16. Female patients who are pregnant or nursing.
17. Any other patients who are regarded as inappropriate to participate to the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified