Changing the future of Oncology.
Criteria for Consideration of Compassionate Use Access to Investigational Medicines in Clinical Trials
Sutro Biopharma will consider providing individual patients compassionate use access to an investigational medicine outside of a clinical trial only when all of the criteria below are met.
Investigational Medicine Must be in Active Clinical Development
The investigational medicine must be part of an active clinical development program (Sutro must be currently studying the medicine in patients).
Granting Access Must Not Interfere with Clinical Trials and Potential Approval
Granting access to an investigational medicine must not interfere with the completion of clinical trials that could support FDA approval of the medicine or otherwise compromise the potential development of the investigational medicine.
Additionally, patients must not be eligible (i.e. do not qualify) for ongoing (or soon opening) clinical trials of the investigational medicine.
A Potential Risk-Benefit Assessment for Patients
The potential benefit to the patient seeking access to the investigational medicine must always be considered to outweigh the collective potential risks to the patient of offering the medicine, including the outcome of the disease itself.
Additionally, patients with underlying medical conditions that may pose safety risks that have not been sufficiently characterized or studied would not be eligible to participate.
As applicable, there is sufficient clinical data to identify an appropriate dose (amount and frequency of the medicine given).
Compassionate Use Access
For the Patient
The patient has:
- A serious, life-threatening illness.
- Exhausted all available therapies typically used to treat the disease and is no longer responsive to, or able to tolerate, these treatments.
- No other viable therapy options, including participation in ongoing relevant clinical trials.
- The request to Sutro for access to the investigational medicine comes from the patient’s qualified physician.
For the Investigational Medicine
- Sutro must have adequate supply of the investigational medicine, taking into account current and projected demand for the investigational medicine in Sutro’s clinical studies.
- In the United States, the FDA and the Institutional Review Board (IRB) (ethics committee that approves and monitors clinical trials involving humans) at the patient’s treating hospital or clinic must review and approve the use of the medicine, in the patient, before Sutro can provide it.
- For additional information, please reach out to: email@example.com.
For the Physician
- The treating physician should request access from Sutro by e-mailing firstname.lastname@example.org; Sutro will evaluate the request according to the criteria set forth above. We respond to all requests as soon as possible, and in most cases we will seek to respond within five business days from receipt.
Sutro’s Commitment to Patients
Cancer has been an unbeatable enemy for too long and for too many people. Advancing cancer treatments, giving patients longer lives and improving their quality of life remains the mission of Sutro Biopharma. By leveraging Sutro’s pioneering technology, we aim to rewrite the future of oncology.
This year alone, more than 1.8 million Americans will receive a cancer diagnosis, and sadly, more than 600,000 will die from the disease.
Sutro and our employees are dedicated to improving survival and quality of life for cancer patients through our innovative research, discovery, development and manufacturing of novel cancer therapeutics.
We believe that Sutro’s revolutionary technology has the potential to change the future of oncology therapeutics; the Sutro team is purposeful in its quest to fully realize the potential of its technology. Sutro is uniquely positioned to chart a path that allows its technology to fully intervene in human disease in a way that no technology previously has. Together with its partners and investors, Sutro is discovering, developing and manufacturing important new therapeutics with a greater precision and a deeper understanding.
 American Cancer Society. Cancer Facts & Figures 2020. Accessed May 2020.
The fight against cancer is in all too familiar. The potential effectiveness and precision of Sutro’s clinical candidates may change the way patients battle cancer. The advancements Sutro has made with our CellFree technology and the ability to manufacture with rigorous GMP standards, is advancing treatment options for patients.
Sutro is currently advancing two wholly owned clinical-stage programs designed to provide patient benefit across multiple areas of unmet need.
STRO-001-BM1 is a CD74 Targeting antibody drug conjugate (ADC) for the potential treatment of multiple myeloma and NHL
- STRO-001-BCM1 is an ongoing first-in-human, phase 1, open-label, multicenter, dose escalation study evaluating the safety, tolerability and preliminary anti-tumor activity of STRO-001-BM1 in adults with B-cell malignancies (NHL and multiple myeloma)
STRO-001-BM1 is a novel homogeneous ADC using precisely positioned non-natural amino acids
- STRO-001-BM1 targets the tumor cell carrying two cytotoxins, these are non-cleavable maytansinoid linker-warheads (DAR=2) that are stable in circulation
- The active warhead is internalized by the tumor cells, efficiently killing them while minimizing damage to surrounding healthy cells.
STRO–001-BM1 has received Orphan Drug designation for Multiple Myeloma patients.
For more information about this trial, visit www.clinicaltrials.gov
STRO-002-GM1 is a FolRa targeting ADC for the potential treatment of ovarian and endometrial cancer
- STRO-002-GM1 is currently in an ongoing first-in-human, phase 1, open-label, multicenter, dose expansion study evaluating the safety, tolerability and preliminary anti-tumor activity of STRO-002-GM1 in adults with ovarian cancer.
- STRO-002 was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in August, 2021 for the treatment of patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior lines of systemic therapy.
STRO-002-GM1 is a novel homogeneous antibody drug conjugate using precisely positioned non-natural amino acids
- STRO-002-GM1 targets the tumor cell carrying four cytotoxins, these are proprietary cleavable hemiasterlin linker-warheads (DAR=4) that are stable in circulation
- The active warhead is internalized by the tumor cell, efficiently killing them in a manner that can stimulate the immune system, an effect called immunogenic cell death.
For more information about this trial, visit www.clinicaltrials.gov
Generation of the CD74 Targeting Antibody and a Novel, Specific, and Homogenous ADC, STRO-001
Using a cell-free expression system, the non-natural amino acid pAMF was incorporated at 2 sites on an antibody that targets CD74. Optimal sites were selected based on conjugation efficiency, cell-killing activity and pharmacokinetics in mice. The cytotoxic non-cleavable maytansinoid linker-warheads are conjugated at the two pAMF sites on the CD74 targeting antibody to generate the ADC STRO-001-BM1.
 Zimmerman ES, et al. Bioconjug Chem2014;255(2);351-361.
Sutro’s technology enables us to design and test complex molecules as potential next generation cancer treatments in a rapid cycle of weeks rather than months. This approach to discovery, without the cell, also transcends the limitations of biologics manufacturing.
Sutro has the world’s only cGMP cell-free manufacturing facility. This state-of-the-art facility, located in San Carlos, California, confers an important competitive advantage in entering clinical development following discovery and pre-clinical assessment of lead development candidate compounds. Currently, Sutro has two wholly owned clinical phase products manufactured in our cGMP facility, STRO-001-BM1 for the intended treatment of multiple myeloma and lymphoma and STRO-002-GM1 for the intended treatment of ovarian and endometrial cancers.
Our Sutro team would like to express our heart-felt thanks to the patients, their families and health care providers for participating in our clinical studies.