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90 Diseases |  |
4 Trials |
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4 Trials |  |
194 News |  |
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- | ganitumab (AMG 479) / Takeda, ImmunityBio
Trial completion date: AEWS1221: Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma (clinicaltrials.gov) - Dec 3, 2024
P3, N=312, Active, not recruiting, Sponsor: National Cancer Institute (NCI)
Trial completion date: Sep 2024 --> Sep 2025
- | ganitumab (AMG 479) / Takeda, ImmunityBio
Phase classification, Combination therapy, Metastases: QUILT-2.019: A Study of AMG 655 or AMG 479 in Combination With Gemcitabine for Treatment of Metastatic Pancreatic Cancer (clinicaltrials.gov) - Oct 17, 2024
P1/2, N=138, Completed, Sponsor: NantCell, Inc.
Trial completion date: Sep 2024 --> Sep 2025 Phase classification: P1b/2 --> P1/2
- ganitumab (AMG 479) / Takeda, ImmunityBio
Phase classification, Enrollment change, Combination therapy, Metastases: QUILT-2.017: Phase 1b/2 Study of AMG 479 in Combination With Paclitaxel and Carboplatin for 1st Line Treatment of Advanced Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov) - Sep 24, 2024
P1/2, N=15, Terminated, Sponsor: NantCell, Inc.
Phase classification: P1b/2 --> P1/2 Phase classification: P1b/2 --> P1/2 | N=49 --> 15
- |||||| ganitumab (AMG 479) / Takeda, ImmunityBio
Phase classification, Trial termination, Combination therapy: QUILT-2.013: First-Line Treatment for Extensive Stage Small Cell Lung Cancer (clinicaltrials.gov) - Aug 23, 2024
P1/2, N=213, Terminated, Sponsor: NantCell, Inc.
Phase classification: P1b/2 --> P1/2 | N=49 --> 15 Phase classification: P1b/2 --> P1/2 | Completed --> Terminated; Subjects discontinued study
- ganitumab (AMG 479) / Takeda, ImmunityBio
Phase classification, Combination therapy, Metastases: QUILT-3.026: AMG 655 in Combination With AMG 479 in Advanced, Refractory Solid Tumors (clinicaltrials.gov) - Aug 20, 2024
P1/2, N=89, Terminated, Sponsor: NantCell, Inc.
Phase classification: P1b/2 --> P1/2 | Completed --> Terminated; Subjects discontinued study Phase classification: P1b/2 --> P1/2
- | ganitumab (AMG 479) / Takeda, ImmunityBio
Phase classification: Panitumumab Combination Study With Rilotumumab or Ganitumab in Wild-type Kirsten Rat Sarcoma Virus Oncogene Homolog (KRAS) Metastatic Colorectal Cancer (mCRC) (clinicaltrials.gov) - Aug 6, 2024
P1/2, N=177, Completed, Sponsor: NantBioScience, Inc.
Phase classification: P1b/2 --> P1/2 Phase classification: P1b/2 --> P1/2
- | Ibrance (palbociclib) / Pfizer, ganitumab (AMG 479) / Takeda, ImmunityBio
Trial termination: Palbociclib + Ganitumab In Ewing Sarcoma (clinicaltrials.gov) - Jul 17, 2024
P2, N=10, Terminated, Sponsor: Dana-Farber Cancer Institute
Phase classification: P1b/2 --> P1/2 Completed --> Terminated; The study closed early due to discontinuation of ganitumab supply.
- ||||||| ganitumab (AMG 479) / Takeda, ImmunityBio
Trial completion, Combination therapy, Metastases: GAMMA: QUILT-2.014: Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the Pancreas (clinicaltrials.gov) - Jul 16, 2024
P3, N=800, Completed, Sponsor: NantCell, Inc.
Completed --> Terminated; The study closed early due to discontinuation of ganitumab supply. Terminated --> Completed
- | Mekinist (trametinib) / Novartis, BeiGene, ganitumab (AMG 479) / Takeda, ImmunityBio
Preclinical, Journal: Preclinical Therapeutic Efficacy of RAF/MEK/ERK and IGF1R/AKT/mTOR Inhibition in Neuroblastoma. (Pubmed Central) - Jul 13, 2024
However, the growth of both primary and metastatic tumors was observed in animals receiving the combination of trametinib and ganitumab. Therefore, more preclinical work is necessary before testing this combination in patients with relapsed or refractory RAS-mutated neuroblastoma.
- ganitumab (AMG 479) / Takeda, ImmunityBio
Association of elevated ctDNA burden following one cycle of chemotherapy with inferior outcomes for patients with metastatic Ewing sarcoma: A report from the Children's Oncology Group (COG). (S504) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3450;
Conversely, ctDNA at a cutpoint of ?0.5% after two cycles of chemotherapy was not prognostic, suggesting either more sensitive assays are needed or the prognostic value of ctDNA burden is diminished following additional therapy. These findings will enable novel trials of risk-adapted therapy focused on baseline and early ctDNA burden.
- | 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) - Mar 11, 2024
P1, N=20, Not yet recruiting, Sponsor: M.D. Anderson Cancer Center
These findings will enable novel trials of risk-adapted therapy focused on baseline and early ctDNA burden. Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025
- ganitumab (AMG 479) / Takeda, ImmunityBio
Low IGFBP7 expression identifies a subset of breast cancers with favorable prognosis and sensitivity to IGF-1 receptor targeting with ganitumab: Data from I-SPY2 and SCAN-B (Section 51) - Mar 5, 2024 - Abstract #AACR2024AACR_3441;
Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025 Abstract is embargoed at this time.
- ||| ganitumab (AMG 479) / Takeda, ImmunityBio
P3 data, Journal, Metastases: Results from the Children's Oncology Group phase III trial of a monoclonal antibody against the insulin-like growth factor-1 receptor in patients with newly diagnosed metastatic Ewing sarcoma. (Pubmed Central) - Nov 16, 2023
Abstract is embargoed at this time. No abstract available
- | ganitumab (AMG 479) / Takeda, ImmunityBio
Trial completion date: AEWS1221: Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma (clinicaltrials.gov) - Oct 18, 2023
P3, N=312, Active, not recruiting, Sponsor: National Cancer Institute (NCI)
No abstract available Trial completion date: Dec 2023 --> Sep 2024
- || ganitumab (AMG 479) / Takeda, ImmunityBio
P1 data, Journal: Phase I trial of ganitumab plus dasatinib to cotarget the insulin-like growth factor 1 receptor and Src family kinase YES in rhabdomyosarcoma. (Pubmed Central) - Sep 4, 2023
P1/2
The combination of dasatinib 60 mg/m2/dose daily and ganitumab 18 mg/kg every two weeks was safe and tolerable. This combination had a disease control rate of 22% at five months.
- || 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.
- ganitumab (AMG 479) / Takeda, ImmunityBio
IGF-1R protein pathway activation is associated with pathologic complete response to an anti-IGF-1R regimen (paclitaxel, ganitumab, and metformin) in the I-SPY2 neoadjuvant breast cancer trial () - Jul 27, 2023 - Abstract #ESMO2023ESMO_1984;
- ||||| ganitumab (AMG 479) / Takeda, ImmunityBio
Clinical, Metastases: Among patients with newly diagnosed metastatic Ewing sarcoma treated with ganitumab plus chemotherapy, the 3-year EFS rate was 39.1%, compared with 37.4% for those given chemotherapy alone. @RLRandallMD @UCD_Cancer #scmsm https://t.co/hiWCqwezTG (Twitter) - Apr 18, 2023
- | 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, Sponsor: M.D. Anderson Cancer Center
This combination lacks adequate therapeutic activity for further study, though a subset of patients had prolonged stable disease. Not yet recruiting --> Recruiting
- || ganitumab (AMG 479) / Takeda, ImmunityBio
P2 data, Journal: Results of TRIO-15, a multicenter, open-label, phase II study of the efficacy and safety of ganitumab in patients with recurrent platinum-sensitive ovarian cancer. (Pubmed Central) - Mar 14, 2023
Not yet recruiting --> Recruiting 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.
- | 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, Sponsor: Dana-Farber Cancer Institute
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
- ||| ganitumab (AMG 479) / Takeda, ImmunityBio
P3 data, Journal, Metastases: Randomized Phase III Trial of Ganitumab With Interval-Compressed Chemotherapy for Patients With Newly Diagnosed Metastatic Ewing Sarcoma: A Report From the Children's Oncology Group. (Pubmed Central) - Jan 21, 2023
Ganitumab added to interval-compressed chemotherapy did not significantly reduce the risk of EFS event in patients with newly diagnosed metastatic Ewing sarcoma, with outcomes similar to prior trials without IGF-1R inhibition or interval compression. The addition of ganitumab may be associated with increased toxicity.
- | ganitumab (AMG 479) / Takeda, ImmunityBio
Trial completion date: AEWS1221: Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma (clinicaltrials.gov) - Dec 23, 2022
P3, N=312, Active, not recruiting, Sponsor: National Cancer Institute (NCI)
The addition of ganitumab may be associated with increased toxicity. Trial completion date: Mar 2023 --> Dec 2023
- | Mekinist (trametinib) / Novartis, ganitumab (AMG 479) / Takeda, ImmunityBio
Journal: The combination of trametinib and ganitumab is effective in RAS-mutated PAX-fusion negative rhabdomyosarcoma models. (Pubmed Central) - Nov 3, 2022
Trial completion date: Mar 2023 --> Dec 2023 We demonstrate that combined trametinib and ganitumab is effective in a genomically diverse panel of RAS-mutated FN RMS preclinical models.
- | 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, Sponsor: Dana-Farber Cancer Institute
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
- | ganitumab (AMG 479) / Takeda, ImmunityBio
Trial completion date: AEWS1221: Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma (clinicaltrials.gov) - Jul 1, 2022
P3, N=312, Active, not recruiting, Sponsor: National Cancer Institute (NCI)
Trial primary completion date: Aug 2022 --> Dec 2022 Trial completion date: Mar 2022 --> Mar 2023
- ganitumab (AMG 479) / Takeda, ImmunityBio
The case for simul-omics: Identifying IO biomarkers of ganitumab-metformin pathological complete response (pCR). () - Apr 28, 2022 - Abstract #ASCO2022ASCO_5960;
predicting pCR, the additive value of TS simulation data over just clinical/SOC data, 2. identification of potentially mechanistic drug targets facilitating GM response, and 3.
- 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.
- | ganitumab (AMG 479) / Takeda, ImmunityBio
Trial termination, Combination therapy: Insulin-like Growth Factor 1 Receptor (IGF-1R) Antibody AMG479 (Ganitumab) in Combination With the Src Family Kinase (SFK) Inhibitor Dasatinib in People With Embryonal and Alveolar Rhabdomyosarcoma (clinicaltrials.gov) - Apr 14, 2022
P1/2, N=14, Terminated, Sponsor: National Cancer Institute (NCI)
Completed --> Terminated; The pharmaceutical company discontinued availability of the drug and we were forced to close the study before phase II was completed. Only one participant was enrolled on phase II.
- | 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, Sponsor: Dana-Farber Cancer Institute
Only one participant was enrolled on phase II. Trial completion date: Aug 2022 --> Dec 2022 | Trial primary completion date: Mar 2022 --> Aug 2022
- | ganitumab (AMG 479) / Takeda, ImmunityBio
Trial completion, Trial completion date, Trial primary completion date, Combination therapy: Insulin-like Growth Factor 1 Receptor (IGF-1R) Antibody AMG479 (Ganitumab) in Combination With the Src Family Kinase (SFK) Inhibitor Dasatinib in People With Embryonal and Alveolar Rhabdomyosarcoma (clinicaltrials.gov) - Feb 1, 2022
P1/2, N=14, Completed, Sponsor: National Cancer Institute (NCI)
Trial completion date: Aug 2022 --> Dec 2022 | Trial primary completion date: Mar 2022 --> Aug 2022 Active, not recruiting --> Completed | Trial completion date: Oct 2022 --> Oct 2021 | Trial primary completion date: Jan 2022 --> Sep 2021
- || ganitumab (AMG 479) / Takeda, ImmunityBio
Clinical, P2 data, Journal: Results of TRIO-14, a phase II, multicenter, randomized, placebo-controlled trial of carboplatin-paclitaxel versus carboplatin-paclitaxel-ganitumab in newly diagnosed epithelial ovarian cancer. (Pubmed Central) - Jan 12, 2022
Addition of ganitumab to CP chemotherapy in primary EOC did not improve PFS. Our results do not support further study of ganitumab in unselected EOC patients.
- | 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, Sponsor: Dana-Farber Cancer Institute
Our results do not support further study of ganitumab in unselected EOC patients. Trial primary completion date: Oct 2021 --> Mar 2022
- Chemokine12 (CK12) tertiary lymphoid gene expression signature as a predictor of response in 3 immunotherapy arms of the neoadjuvant ISPY 2 TRIAL - pembrolizumab with and without SD101, and durvalumab combined with olaparib - and in 9 other arms of the trial including platinum-based and dual-anti-HER2 therapies (Stars at Night 1/2) - Oct 26, 2021 - Abstract #SABCS2021SABCS_1507;
The CK12 signature is highly predictive of complete pathologic response to immuno-oncology agents and other therapeutics supporting the role of the crosstalk within the tumor immune microenvironment in predicting response across subtypes. This gene expression signature can be readily obtained from microarrays and warrants further investigation in future arms of ISPY2 as a predictive biomarker.
- | 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, Sponsor: M.D. Anderson Cancer Center
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.
- ||||| metformin / Generic mfg., ganitumab (AMG479) / Takeda, ImmunityBio, paclitaxel / Generic mfg.
Combination therapy: Ganitumab is a monoclonal antibody designed to bind and inhibit function of the type I insulin-like growth factor receptor💡In this #study Ganitumab was tested in combination with #metformin and paclitaxel followed by AC compared to standard-of-care alone https://t.co/9KQJNCPeNr (Twitter) - Oct 6, 2021
- | ganitumab (AMG 479) / Takeda, ImmunityBio
Enrollment closed, Enrollment change, Combination therapy: Insulin-like Growth Factor 1 Receptor (IGF-1R) Antibody AMG479 (Ganitumab) in Combination With the Src Family Kinase (SFK) Inhibitor Dasatinib in People With Embryonal and Alveolar Rhabdomyosarcoma (clinicaltrials.gov) - Sep 16, 2021
P1/2, N=13, Active, not recruiting, Sponsor: National Cancer Institute (NCI)
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. Recruiting --> Active, not recruiting | N=40 --> 13
- | 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, Sponsor: Dana-Farber Cancer Institute
Recruiting --> Active, not recruiting | N=40 --> 13 Recruiting --> Active, not recruiting
- | Biomarker, Trial completion date, Trial primary completion date: I-SPY 2: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (clinicaltrials.gov) - Aug 27, 2021
P2, N=4000, Recruiting, Sponsor: QuantumLeap Healthcare Collaborative
Recruiting --> Active, not recruiting Trial completion date: Dec 2026 --> Dec 2031 | Trial primary completion date: Dec 2025 --> Dec 2030
- | ganitumab (AMG 479) / Takeda, ImmunityBio
Trial primary completion date: AEWS1221: Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma (clinicaltrials.gov) - Apr 22, 2021
P3, N=312, Active, not recruiting, Sponsor: National Cancer Institute (NCI)
Trial completion date: Dec 2026 --> Dec 2031 | Trial primary completion date: Dec 2025 --> Dec 2030 Trial primary completion date: Mar 2022 --> Mar 2021
- | Biomarker, Phase classification: I-SPY 2: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (clinicaltrials.gov) - Feb 16, 2021
P2, N=4000, Recruiting, Sponsor: QuantumLeap Healthcare Collaborative
Trial primary completion date: Mar 2022 --> Mar 2021 Phase classification: P1 --> P2
- | ganitumab (AMG 479) / Takeda, ImmunityBio
Trial primary completion date: AEWS1221: Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma (clinicaltrials.gov) - Jan 6, 2021
P3, N=330, Active, not recruiting, Sponsor: National Cancer Institute (NCI)
Phase classification: P1 --> P2 Trial primary completion date: Nov 2021 --> Mar 2021
- Mektovi (binimetinib) / Pfizer
Phase classification, Metastases: A Study of MEK162 and AMG 479 in Patients With Selected Solid Tumors (clinicaltrials.gov) - Dec 10, 2020
P1/2, N=77, Terminated, Sponsor: Pfizer
Trial primary completion date: Nov 2021 --> Mar 2021 Phase classification: P2 --> P1/2
- | ganitumab (AMG 479) / Takeda, ImmunityBio
Trial completion date, Trial primary completion date, Combination therapy: Insulin-like Growth Factor 1 Receptor (IGF-1R) Antibody AMG479 (Ganitumab) in Combination With the Src Family Kinase (SFK) Inhibitor Dasatinib in People With Embryonal and Alveolar Rhabdomyosarcoma (clinicaltrials.gov) - Dec 4, 2020
P1/2, N=40, Recruiting, Sponsor: National Cancer Institute (NCI)
Phase classification: P2 --> P1/2 Trial completion date: Oct 2021 --> Oct 2022 | Trial primary completion date: Jan 2021 --> Jan 2022
- | Biomarker, Phase classification, PARP Biomarker, PD(L)-1 Biomarker: I-SPY 2: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (clinicaltrials.gov) - Oct 14, 2020
P1, N=4000, Recruiting, Sponsor: QuantumLeap Healthcare Collaborative
Trial completion date: Oct 2021 --> Oct 2022 | Trial primary completion date: Jan 2021 --> Jan 2022 Phase classification: P2 --> P1
- ganitumab (AMG479) / Takeda, NantWorks
[VIRTUAL] Biomarker analysis of paclitaxel, ganitumab, and metformin (PGM) therapy in the I-SPY2 neoadjuvant clinical trial (OnDemand) - Oct 2, 2020 - Abstract #SABCS2020SABCS_338;
While IGF gene expression profiling associated with treatment response, they were not specific for PGM. Further, biomarker analysis and strategies to control glucose will be needed to optimize anti-IGF-1R therapies.
- Mekinist (trametinib) / Novartis, ganitumab (AMG479) / Takeda, NantWorks
[VIRTUAL] Preclinical therapeutic synergy of MEK1/2 and IGF1R inhibition in RAS-driven rhabdomyosarcoma () - Sep 7, 2020 - Abstract #AACRNCIEORTC2020AACR_NCI_EORTC_312;
We demonstrate that combined trametinib and ganitumab treatment shows therapeutic synergy across a wide panel of RAS-mutated RMS preclinical models. These data support testing this combination in a phase I/II clinical trial for pediatric patients with relapsed or refractory RAS-mutated RMS.