- |||||||||| Ibrance (palbociclib) / Pfizer, ganitumab (AMG 479) / Takeda, ImmunityBio
P2 data, Clinical Trial,Phase II, Journal: Phase 2 trial of palbociclib and ganitumab in patients with relapsed Ewing sarcoma. (Pubmed Central) - Aug 14, 2023 This combination had a disease control rate of 22% at five months. This combination lacks adequate therapeutic activity for further study, though a subset of patients had prolonged stable disease.
- |||||||||| Votrient (pazopanib) / Novartis, BeiGene, ganitumab (AMG 479) / Takeda, ImmunityBio, Torisel (temsirolimus) / Pfizer
Enrollment open, Metastases: Implantable Microdevice for the Delivery of Drugs and Their Effect on Tumors in Patients With Metastatic or Recurrent Sarcoma (clinicaltrials.gov) - Mar 15, 2023 P1, N=20, Recruiting, This combination lacks adequate therapeutic activity for further study, though a subset of patients had prolonged stable disease. Not yet recruiting --> Recruiting
- |||||||||| Ibrance (palbociclib) / Pfizer, ganitumab (AMG 479) / Takeda, ImmunityBio
Trial completion, Enrollment change: Palbociclib + Ganitumab In Ewing Sarcoma (clinicaltrials.gov) - Feb 14, 2023 P2, N=10, Completed, IGF1R inhibition with ganitumab was well-tolerated, however, our results do not support further study of ganitumab as a single agent in unselected OC patients. Active, not recruiting --> Completed | N=18 --> 10
- |||||||||| Ibrance (palbociclib) / Pfizer, ganitumab (AMG 479) / Takeda, ImmunityBio
Trial primary completion date: Palbociclib + Ganitumab In Ewing Sarcoma (clinicaltrials.gov) - Sep 19, 2022 P2, N=18, Active, not recruiting, We demonstrate that combined trametinib and ganitumab is effective in a genomically diverse panel of RAS-mutated FN RMS preclinical models. Trial primary completion date: Aug 2022 --> Dec 2022
- |||||||||| Improved pathologic complete response rates for triple-negative breast cancer in the I-SPY2 Trial. (Available On Demand; 362) - Apr 28, 2022 - Abstract #ASCO2022ASCO_3288;
P2 As a platform phase 2 trial it utilizes an adaptive design to compare new regimens with control chemotherapy (weekly paclitaxel followed by AC)...Only veliparib and carboplatin (VC) and pembrolizumab (Pembro) met the graduation criteria for TNBC...For tumors that are neither immune enhanced or DRD-positive (Immune-/DRD-; 25%) show numerically improved pCR rates for neratinib (20%), MK2206 (25%), ganitumab (24%), and ganetespib (22%) compared to control (12%)... Further refinement of TNBC signatures should yield improved therapeutic strategies while also sparing women unnecessary systemic therapy.
- |||||||||| Ibrance (palbociclib) / Pfizer, ganitumab (AMG 479) / Takeda, ImmunityBio
Phase 2 trial of palbociclib and ganitumab in patients with relapsed Ewing sarcoma. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_3180; P2 With 0/10 responders, we concluded that this combination lacked adequate therapeutic activity for further study. The combination was tolerable at a palbociclib dose of 100 mg, with primarily hematologic toxicity in patients with relapsed EwS.
- |||||||||| ganitumab (AMG 479) / Takeda, ImmunityBio
Results of a phase I trial of ganitumab plus dasatinib in patients with rhabdomyosarcoma (RMS). (Available On Demand; 465) - Apr 28, 2022 - Abstract #ASCO2022ASCO_3133; P1/2 Once daily dasatinib at 60 mg/m2/dose (max 100 mg) combined with 18 mg/kg ganitumab every 2 weeks was determined to be the MTD. PR and SD for > 4 months were observed in this phase I trial suggesting that the addition of a YES-targeting agent may delay the development of acquired resistance to IGF-1R antibody therapy in RMS.
- |||||||||| Ibrance (palbociclib) / Pfizer, ganitumab (AMG 479) / Takeda, ImmunityBio
Trial completion date, Trial primary completion date: Palbociclib + Ganitumab In Ewing Sarcoma (clinicaltrials.gov) - Mar 23, 2022 P2, N=18, Active, not recruiting, Only one participant was enrolled on phase II. Trial completion date: Aug 2022 --> Dec 2022 | Trial primary completion date: Mar 2022 --> Aug 2022
- |||||||||| Ibrance (palbociclib) / Pfizer, ganitumab (AMG 479) / Takeda, ImmunityBio
Trial primary completion date: Palbociclib + Ganitumab In Ewing Sarcoma (clinicaltrials.gov) - Nov 16, 2021 P2, N=18, Active, not recruiting, Our results do not support further study of ganitumab in unselected EOC patients. Trial primary completion date: Oct 2021 --> Mar 2022
- |||||||||| Votrient (pazopanib) / Novartis, BeiGene, ganitumab (AMG 479) / Takeda, ImmunityBio, Torisel (temsirolimus) / Pfizer
Trial completion date, Trial primary completion date, Metastases: Implantable Microdevice for the Delivery of Drugs and Their Effect on Tumors in Patients With Metastatic or Recurrent Sarcoma (clinicaltrials.gov) - Oct 14, 2021 P1, N=20, Not yet recruiting, This gene expression signature can be readily obtained from microarrays and warrants further investigation in future arms of ISPY2 as a predictive biomarker. Trial completion date: Jul 2021 --> Dec 2024 | Trial primary completion date: Jul 2021 --> Dec 2024
- |||||||||| ganitumab (AMG479) / Takeda, ImmunityBio
Clinical, Journal: Ganitumab and metformin plus standard neoadjuvant therapy in stage 2/3 breast cancer. (Pubmed Central) - Oct 7, 2021 None were specific predictors of response to PGM, although several signatures were associated with pCR in both arms. Any further development of anti-IGF-1R therapy will require better control of anti-IGF-1R drug-induced hyperglycemia and the development of more predictive biomarkers.
- |||||||||| Ibrance (palbociclib) / Pfizer, ganitumab (AMG 479) / Takeda, ImmunityBio
Enrollment closed: Palbociclib + Ganitumab In Ewing Sarcoma (clinicaltrials.gov) - Aug 31, 2021 P2, N=18, Active, not recruiting, Recruiting --> Active, not recruiting | N=40 --> 13 Recruiting --> Active, not recruiting
- |||||||||| ganitumab (AMG479) / Takeda, NantWorks
[VIRTUAL] PNEUMONITIS AFTER WHOLE LUNG IRRADIATION ON CHILDREN'S ONCOLOGY GROUP AEWS1221 (Hall 4) - Aug 26, 2020 - Abstract #SIOP2020SIOP_1198; Of patients with pneumonitis, 4 were female and 5 were randomized to the trial experimental arm and received the study drug ganitumab prior to WLI...Average V20 for patients experiencing pneumonitis exceeded study guidelines. Future efforts are underway to evaluate radiotherapy variables that may impact the risk of pneumonitis including mean lung dose, lung V20 and lung V30, and compare these to patients who did not develop pneumonitis.
- |||||||||| RELAPSED METASTATIC EWING SARCOMA INITIALLY RESPONSIVE TO DINUTUXIMAB IN A PEDIATRIC PATIENT () - Apr 3, 2020 - Abstract #ASPHO2020ASPHO_319;
We present a case of a patient with relapsed Ewing sarcoma whose tumor appears to have responded to Dinutuximab. While this is one patient and we did not have the ability to assess the extent or duration of response, these findings further support the need for clinical trials evaluating Dinutuximab therapy for relapsed Ewing sarcoma.
- |||||||||| conatumumab (AMG 655) / Amgen
Trial completion: Open Label Extension Study of Conatumumab and Ganitumab (AMG 479) (clinicaltrials.gov) - Apr 1, 2020 P2, N=12, Completed, While this is one patient and we did not have the ability to assess the extent or duration of response, these findings further support the need for clinical trials evaluating Dinutuximab therapy for relapsed Ewing sarcoma. Active, not recruiting --> Completed
- |||||||||| Votrient (pazopanib) / Novartis, BeiGene, ganitumab (AMG 479) / Takeda, ImmunityBio, Torisel (temsirolimus) / Pfizer
Trial initiation date, Metastases: Implantable Microdevice for the Delivery of Drugs and Their Effect on Tumors in Patients With Metastatic or Recurrent Sarcoma (clinicaltrials.gov) - Mar 6, 2020 P1, N=20, Not yet recruiting, Active, not recruiting --> Completed Initiation date: Jan 2020 --> May 2020
- |||||||||| Application of Machine Learning to elucidate the biology predicting response in the I SPY 2 neoadjuvant breast cancer trial (Atrium) - Feb 28, 2020 - Abstract #BOP2020BOP_48;
Our study involves 986 patients with pre treatment gene expression and pCR data across 10 treatment arms including inhibitors of HER2: neratinib (N), pertuzumab (P), TDM1/P; AKT (MK 2206; M); IGF1R (ganitumab); HSP90 (ganetespib); PARP/DNA repair (veliparib/carboplatin; VC); ANG 1/2 (AMG386); immune checkpoints (pembrolizumab; Pembro); and a shared control arm (Ctr). Our results suggests that hypothesis driven analysis restricted to assumed mechanisms of action of the experimental agents may be insufficient, and that exploration of possible off target effects may be needed to understand the underlying biology of response or resistance.
- |||||||||| Biomarker, Enrollment change, PARP Biomarker, PD(L)-1 Biomarker: I-SPY 2: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (clinicaltrials.gov) - Feb 10, 2020
P2, N=4000, Recruiting, Our results suggests that hypothesis driven analysis restricted to assumed mechanisms of action of the experimental agents may be insufficient, and that exploration of possible off target effects may be needed to understand the underlying biology of response or resistance. N=1920 --> 4000
- |||||||||| conatumumab (AMG 655) / Amgen
Trial completion date, Trial primary completion date: Open Label Extension Study of Conatumumab and Ganitumab (AMG 479) (clinicaltrials.gov) - Dec 19, 2019 P2, N=12, Active, not recruiting, Trial primary completion date: Dec 2020 --> Dec 2025 Trial completion date: Nov 2019 --> Mar 2020 | Trial primary completion date: Sep 2019 --> Mar 2020
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