Solid Tumor - disitamab vedotin - HER-2 positive

Association details:

Biomarker:	HER-2 positive
Cancer:	Solid Tumor
Drug:	Aidixi (disitamab vedotin) (Microtubule inhibitor, HER2-targeted antibody-drug conjugate)
Direction:	Sensitive

Evidence:

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

A Study of RC48-ADC for the Treatment of HER2-expression Metastatic Breast Cancer With Abnormal Activation of PAM Pathway

Excerpt:

...Patients with HER2-positive metastatic breast cancer have received treatment with trastuzumab or its biosimilar (monotherapy or in combination with other drugs, such as for ≥ 3 months in the adjuvant therapy phase, and ≥ 6 weeks in the post-relapse and metastatic phase); 8....

Trial ID:

NCT05331326

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

A Phase II Study of RC48-ADC in Subjects With HER2 Positive Metastatic or Unresectable Urothelial Cancer

Excerpt:

...- HER2-positive status confirmed by the central laboratory: IHC 2+ or 3+; Subject is able to provide specimens from primary or metastatic lesions for HER2 tests...

Trial ID:

RC48-C005

More C2 evidence

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases

Excerpt:

...- Positive HER2 expression (positive defined as: IHC 3+ or FISH+); previous test results of HER2 expression provided by the subjects (have to be confirmed by the investigator) and those obtained from the study site or the central laboratory were both acceptable; subject are able to provide samples from primary or metastatic tumor sites for HER2 test (either paraffin blocks, paraffin-embedded sections, or sections prepared using freshly excised tissues);...

Trial ID:

NCT03500380

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

RC48 for Neoadjuvant Chemotherapy of HER2 Positive Breast Cancer

Excerpt:

...Patients with early or locally advanced breast cancer who are HER2-positive, have a tumor larger than 2 cm and/or have lymph node metastasis: HER2-positive is defined as 3 + by immunohistochemistry, or 2 + by immunohistochemistry, with a positive FISH test....

Trial ID:

NCT05134519

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrialsregister.eu

Title:

A single-arm, multi-center, prospective phase II clinical trial of the efficacy and safety of intracranial fractionated stereotactic radiotherapy (SRT) combined with disitamabVedotin (RC48) in the treatment of HER2-positive breast cancer patients with brain metastases

Excerpt:

...Patients must have pathologically confirmed HER2-positive breast cancer, defined as IHC 3+ or IHC 2+,FISH+, primary or metastatic tissue; 4. ...

Trial ID:

ChiCTR2300070487

Evidence Level:

Sensitive: C3 – Early Trials

Source:

Gastric Cancer

Title:

Phase I study of the recombinant humanized anti-HER2 monoclonal antibody–MMAE conjugate RC48-ADC in patients with HER2-positive advanced solid tumors.

Published date:

05/04/2021

Excerpt:

Fifty-seven patients were enrolled...RC48 also showed promising efficacy, with ORR of 15.0% (3/20) and DCR of 45.0% (9/20)....RC48 was well tolerated and showed promising antitumor activity in HER2-positive solid tumors, including gastric cancer...

DOI:

https://doi.org/10.1007/s10120-021-01168-7

Trial ID:

NCT02881190