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On Going Trials
Phase 1 dose escalation of IMC-F106C
Trail Link: https://clinicaltrials.gov/ct2/show/NCT04262466
The first PRAME × CD3 ImmTAC bispecific protein in solid tumors.
•TCR bispecific proteins redirect polyclonal T cells to target intra- or extra-cellular cancer proteins (>90% of proteome)
•ImmTAC molecules are validated by tebentafusp (gp100 × CD3) with OS benefit in uveal melanoma (HR 0.51)1
Key eligibility criteria
•HLA-A*02:01 (central testing)
•Select advanced solid tumors
•Tumor PRAME by immunohistochemistry
-High PRAME prevalence: enroll all comers; test retrospectively
-All other indications: prospective confirmation of PRAME
C4 Therapeutics BRD9 protein degrader
Trial link: https://clinicaltrials.gov/ct2/show/NCT05355753
The drug is CFT8634 a BRD9 protein degrader.
A Phase 1/2 Open-Label, Multicenter Study to Characterize the Safety and Tolerability of CFT8634 in Subjects With Locally Advanced or Metastatic SMARCB1-Perturbed Cancers, Including Synovial Sarcoma and SMARCB1-Null Tumors
UPDATE 11/2/23 https://www.fiercebiotech.com/biotech/c4-therapeutics-discontinues-cancer-program-waits-betta-payment C4 Therapeutics is discontinuing one of its cancer assets after a phase 1/2 trial proved the drug ineffective.
The small molecule medicines biotech has ended development of CFT8634, an oral BRD9 degrader, in synovial sarcoma
While the drug appeared to be well tolerated, high levels of BRD9 degradation didn’t result in sufficient efficacy for heavily pre-treated patients receiving CFT8634 by itself.
By downregulating c-MYC and MCL-1, it may be possible to achieve apoptosis in different kinds of tumor cells with TP-1287.
Orphan Drug Designation - TP-1287 oral CDK9 inhibitor
Trail Link: https://clinicaltrials.gov/ct2/show/NCT03604783
FDA has given TP-1287, an investigational oral CDK9 inhibitor, orphan drug designation for the treatment of patients with sarcoma, Ewing sarcoma, dedifferentiated liposarcoma, and synovial sarcoma.
The regulatory organization also gave TP-1287 rare pediatric disease designation. An ongoing phase 1 trial (NCT03604783) is evaluating the efficacy of TP-1287 in a population of patients with metastatic or progressive solid tumors that are refractory or intolerant to other available therapies. This includes patients with sarcoma, Ewing sarcoma, dedifferentiated liposarcoma, and synovial sarcoma.
Foghorn FHD-609 Selective Protein Degrader of BRD9
Trail Link: https://clinicaltrials.gov/ct2/show/NCT04965753
HD-609 is a potent, selective protein degrader of BRD9 (bromodomain-containing protein 9), a subunit of ncBAF (non-canonical BAF complex). Substantially all synovial sarcoma cancers contain a translocation, a type of mutation between a BAF subunit gene SS18 and another set of genes SSX. These mutations render the cancer genetically dependent upon BRD9, what is commonly referred to as a synthetic lethal relationship.
SPEARHEAD-1 (afamitresgene autoleucel ‘afami-cel’; formerly ADP-A2M4)
SPEARHEAD-1 (afamitresgene autoleucel ‘afami-cel’; formerly ADP-A2M4)
Trail Link: https://clinicaltrials.gov/ct2/show/NCT04044768?spons=Adaptimmune
This is a Phase 2, open-label, single arm clinical trial to evaluate the anti-tumor activity of ADP-A2M4 SPEAR T-cells in patients who are HLA-A*02 positive and have inoperable locally advanced synovial sarcoma or myxoid/round cell liposarcoma (MRCLS) expressing MAGE-A4. Enrollment for Cohort 1 is now closed, enrolment of Cohort 2 is still open.
INT230-6 Shows Promising Efficacy, Safety in Sarcomas
INT230-6 Shows Promising Efficacy, Safety in Sarcomas; Investigators are designing a phase 3 study to compare INT230-6 as a monotherapy with standard-of-care pazopanib (Votrient), trabectedin (Yondelis), and eribulin (Halaven) in patients with relapsed, refractory, and metastatic sarcomas.
https://www.targetedonc.com/view/int230-6-shows-promising-efficacy-safety-in-sarcomas
Valo Therapeutics Announces Regulatory Approval to Expand Phase I Immuno-oncology Trial into Synovial Sarcoma
Valo Therapeutics Oy (ValoTx), the developer of novel, adaptable immunotherapies for cancer, announces it has received approval from Germany’s PEI (Paul Ehrlich Institute) to extend the tumor types to be treated in the company’s current Phase I trial into two subtypes of sarcoma. The subtypes, synovial and myxoid round cell sarcoma, have high levels of expression of the well-known, tumor specific antigen targets MAGE-A3 and NY-ESO-1, and hence are an ideal target for ValoTx’s lead cancer immunotherapy program, PeptiCRAd-1 (Peptide-coated Conditionally Replicating Adenovirus 1). PeptiCRAd-1 is made up of ValoTx’s proprietary oncolytic virus, VALO-D102, coated with MAGE-A3 and NY-ESO-1 peptides. No other oncolytic virus therapy targets tumor antigens in this way.
https://clinicaltrials.gov/study/NCT05492682
First-In-Human Phase 1 Trial of T-Cell Membrane-Anchored Tumor Targeted Il12 (Attil12)- T-Cell Therapy in Subjects With Advanced/Metastatic Soft Tissue and Bone Sarcoma
First-In-Human Phase 1 Trial of T-Cell Membrane-Anchored Tumor Targeted Il12 (Attil12)- T-Cell Therapy in Subjects With Advanced/Metastatic Soft Tissue and Bone Sarcoma
https://clinicaltrials.gov/study/NCT05621668
https://clinicaltrials.gov/study/NCT05621668
Part A. Determine the safety, maximum tolerated dose and/or recommended phase 2 dose of adoptively transferred autologous tumor-targeted IL12 T cells (attIL12 T cell therapy) in combination with cyclophosphamide in patients with advanced/metastatic soft tissue or bone sarcomas
Part B. Characterize the safety and tolerability and assess preliminary efficacy of attIL12-armed T cells in combination with cyclophosphamide by evaluating the 4-month disease control rate (DCR4 months) in patients with recurrent unresectable osteosarcoma
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