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RecruitingLast updated: 18 April 2024

MoST Addendum 8: This Phase II study is trying to understand how effective a targeted therapy (trastuzumab emtansine) is in people with cancers with HER2 amplifications or mutationsSingle arm, open label, signal seeking, phase IIa trial of the activity of Trastuzumab emtansine (T-DM1) in patients with tumours harbouring HER2 amplifications or mutations

Clinical summary

Summary

Trastuzumab emtansine will be administered intravenously at a dose of 3.6 mg/kg every 21 days continuously until disease progression is documented, the patient experiences an intolerable toxicity, or withdraws for another reason.

Conditions

This trial is treating patients with solid cancers with HER2 amplifications or mutations

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

II

Trial Acronym

MoST Addendum 8

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Australian Genomic Cancer Medicine Centre,University of Sydney

Scientific Title

Single arm, open label, signal seeking, phase IIa trial of the activity of Trastuzumab emtansine (T-DM1) in patients with tumours harbouring HER2 amplifications or mutations

Eligibility

Inclusion

 Male or female participants, aged 18 years and older, with either
a. advanced and/or metastatic solid cancer of any histologic type, refractory or unsuitable for standard therapies for that cancer type; or
b. newly diagnosed metastatic, non-squamous NSCLC
2. Patients with tumours harbouring HER2 mutations or amplification (in the absence of a mutation) identified using comprehensive genomic profiling (CGP) and determined by the molecular tumour board. (Exception: ASPiRATION participants with HER2 mutation with/without amplification are eligible).
3. Confirmation of molecular eligibility by the molecular tumour board
4. Measurable disease as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and/or RANO. (Exception: ASPiRATION participants with evaluable but non-measurable disease may be approved on a case-by-case basis by contacting the ASPiRATION study chair or delegate through the NHMRC CTC).
5. ECOG 0-2
6. If the CNS is involved (either primary or metastatic disease), this must be asymptomatic or previously treated and controlled either with local treatment or by steroids
7. Adequate organ system function as assessed by the following minimal laboratory requirements (within 7 days prior to first administration of study drug):
a. bone marrow function; platelets equal or more than 100 x 10^9/L, ANC equal or more than 1.5 x 10^9/L, and haemoglobin equal or more than 9g/dL (5.6mmol/L);
b. liver function; ALT/AST equal or less than 2.5 x ULN and total bilirubin equal or less than 1.5xULN;
c. renal function: creatinine clearance greater than 50 mL/min based on Cockcroft-Gault glomerular filtration rate (GFR) estimation: (140 - Age) × (weight in kg) × (0.85 if female)/(72 × serum creatinine);
8. Prior anticancer therapy (excluding HER2 inhibitors)
a. For newly diagnosed metastatic, non-squamous NSCLC:
i. Up to 2 cycles of systemic therapy while awaiting the results of CGP testing are permitted (but not required);
b. For advanced and/or metastatic treatment-refractory solid cancer of any histologic type:
i. Participants must have received and failed all standard anticancer therapy or have documented unsuitability for any further standard therapy, if standard therapy exists.
ii. Clinical or radiological progression on, or following last anticancer therapy unless such anticancer therapy stopped due to toxicity / treatment intolerance
9. ALP equal or less than 2.5 ×ULN with the following exception: patients with bone metastases: ALP equal of less than 5 ×ULN
10. INR and aPTT less then 1.5 x ULN (unless on therapeutic coagulation)
11. Albumin equal or more than 25mg/dL
12. Life expectancy greater than or equal to 12 weeks

Exclusion

1. Known history of hypersensitivity or contraindication to T-DM1;
2. Prior treatment with T-DM1, or other HER2-directed therapy;
3. HER2-amplified breast and gastric cancer (breast and gastric cancer with HER2 mutations are permitted);
4. Peripheral neuropathy of grade 2 or higher (according to National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE], version 5);
5. History of recent (within 3 months prior to screening) symptomatic congestive heart failure or clinically significant cardiac dysfunction as determined by left ventricular ejection fraction (LVEF) less than 50%;
6. Currently diagnosed with interstitial lung disease, interstitial fibrosis or history of tyrosine kinase inhibitor-induced pneumonitis
7. Specific comorbidities or conditions (e.g. psychiatric) or concomitant medications which may interact with the investigational product(s);
8. Co-morbidities or conditions that may compromise assessment of key outcomes or in the opinion of the clinician, limit the ability of the patient to comply with the protocol;
9. Radiation therapy, major surgery or tumour embolization within 14 days prior to the first dose of T-DM1;
10. Any systemic therapy within 28 days prior to the first dose of T-DM1. Any systemic therapy within 21 days prior to the first dose of T-DM1 for ASPiRATION cohort participants who received systemic therapy while awaiting the results of CGP testing.;
11. Any unresolved toxicity ( greater than CTCAE v5.0 grade 2) from previous anti-cancer therapy;
12. Prior or concurrent malignancy except for:
a. Malignancy treated with curative intent and with no known active disease within 2 years before consent to molecular screening and of low potential risk for recurrence;
b. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease;
c. Adequately treated carcinoma-in-situ without evidence of disease
13. Pregnancy, lactation, or inadequate contraception.

Inclusion

  • You have had treatment, but your cancer has come back.
  • Your cancer has spread to other parts of the body.
  • Your cancer has not spread to other parts of the body.
  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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