A Study of AIP-303 in HER2 Positive Breast Cancer and/or Metastatic Breast Cancer Patients (Heroine01)
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|ClinicalTrials.gov Identifier: NCT04469127|
Recruitment Status : Not yet recruiting
First Posted : July 13, 2020
Last Update Posted : July 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|HER2 Positive Breast Cancer||Drug: AIP-303||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Multicenter, Open-Label Study of AIP-303, for HER2-Positive Unresectable and/or Metastatic Breast Cancer Patients Resistant or Refractory to Trastuzumab or Ado-Trastuzumab and Chemotherapy (Heroine-Breast 01)|
|Estimated Study Start Date :||August 30, 2020|
|Estimated Primary Completion Date :||August 30, 2021|
|Estimated Study Completion Date :||August 30, 2021|
Experimental: Arm 1
Single Arm study
Study participants be administered therapeutic doses of AIP-303 up to four treatments spaced 8 weeks apart and a CT scan immediately after. An AIP 301 Ga-68 PET/CT scan will be performed four weeks before and four weeks after the initial dose of the AIP-303.
- Specific Aim 1 [ Time Frame: 6 Months ]
Demonstrate safety, tolerability and side-effects of the standard dose of 7.4 GBq (200 mCi). (Phase Ib).
Measurements used to assess the safety, tolerability and side-effects profile will include adverse events of any grade, grade 3 and 4 adverse events, withdrawals due to adverse events and dose reductions due to adverse events. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v.5.0) will be used to evaluate AE grade.
- Specific Aim 2 [ Time Frame: 6 Months ]1. PFS (Phase Ib/II). Percentage of subjects still alive without disease getting worse or without progression (according to RECIST 5.0 Criteria).
- Specific Aim 3 [ Time Frame: 6 Months ]2. ORR (Phase II): Percentage of subjects still alive. Percentage of subjects who achieved a best overall response
- Specific Aim 4 [ Time Frame: 6 Months ]3. Demonstrate Time to Response: Time to response is defined as the time from the start of treatment until first documented evidence of PR or CR (whichever status is recorded first) (Phase Ib/II).
- Specific Aim 5 [ Time Frame: 6 Months ]4. Demonstrate Duration of Response: [Time Frame: From the first documented evidence of a CR or a PR until the first documented sign of disease progression or death, whichever occurred earlier (up to 180 Days).]
- Specific Aim 6 [ Time Frame: 6 Months ]5. OS (Phase Ib): Percentage of subjects still alive. Percentage of subjects who achieved best overall survival.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04469127
|Contact: Stanley Satz, Ph.D.||561-561 email@example.com|
|Contact: Rose Satzfirstname.lastname@example.org|
|United States, Iowa|
|Department of Veterans Affairs|
|Iowa City, Iowa, United States, 52242|
|Contact: David L Bushnell, M.D. 319-384-7306 email@example.com|
|Santiago, Chile, 878|
|Contact: Horatio Amaral, M.D. +56 2 24205137 firstname.lastname@example.org|
|All India Institute of Medical Sciences|
|New Delhi, Dehli, India, 110029|
|Contact: C.S. Bal, M.D./Ph.D. email@example.com|
|Postgraduate Institute of Medical and Research|
|Chandigarh, India, 160 012|
|Contact: Br Mittal, M.D./Ph.D. +911722756722 firstname.lastname@example.org|
|Università degli Studi di Trieste|
|Cremona, Italy, 26100|
|Contact: Daniele Generali, M.D. +39(0)372408042 email@example.com|
|University of Witwatersrand|
|Johannesburg, South Africa, 2000|
|Contact: Mboyo Di-Tamba Vangu, M.D./Ph.D. Mboyo-Di-Tamba.Vangu@wits.ac.za|
|University of Lausanne|
|Lausanne, Switzerland, 1011|
|Contact: John O Prior, M.D. +41 21 314 3048 John.Prior@chuv.ch|
|Study Director:||Stanley Satz, Ph.D.||Advanced Imaging Projects|