Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
APX005M · 3 trials · 11 indications
The pCR was defined as post-neoadjuvant pathologic tumour, node, metastasis (ypTNM) (after chemoRT; after surgery) with T0, N0 stages. pCR rate was defined as the percentage of participants who achieved a pCR at surgery, as assessed by the Investigator. * T0: No evidence of primary tumor. * N0: Cancer has not spread to nearby lymph nodes. An exact Clopper-Pearson lower 95% confidence limit was used to test the null hypothesis that the pCR rate is ≤30%.
The pCR was defined as ypTNM (after chemoRT; after surgery) with T0, N0 stages. pCR rate was defined as the percentage of participants who achieved a pCR at surgery, as assessed by the Investigator. An exact Clopper-Pearson lower 95% confidence limit was used to test the null hypothesis that the pCR rate is ≤30%.
The pCR was defined as ypTNM (after chemoRT; after surgery) with T0, N0 stages. pCR rate was defined as the percentage of participants who achieved a pCR at surgery, as assessed by the Investigator. An exact Clopper-Pearson lower 95% confidence limit was used to test the null hypothesis that the pCR rate is ≤30%.
The pCR was defined as ypTNM (after chemoRT; after surgery) with T0, N0 stages. pCR rate was defined as the percentage of participants who achieved a pCR at surgery, as assessed by the Investigator. Steroids use: Yes was defined as participants with any steroid (ATC2 class corticosteroids for systemic use) from within 30 days of the first dose of sotigalimab to up to 7 days after the first dose and participants not fulfilling previous requirements are defined as Steroids use: No. An exact Clopper-Pearson lower 95% confidence limit was used to test the null hypothesis that the pCR rate is ≤30%.
The pCR was defined as ypTNM (after chemoRT; after surgery) with T0, N0 stages. pCR rate was defined as the percentage of participants who achieved a pCR at surgery, as assessed by the Investigator. The subgroup of participants who had surgery before or at 16/17 weeks were defined as start of study treatment to surgery date from the surgical resection form, less than or equal to 17 weeks (119 days = 17 weeks \* 7 days) or participants who were scheduled to have surgery but had their procedure aborted due to progressive disease at the time of the procedure or immediately before and did not have surgery because of metastasis. The subgroup of participants who had surgery after Week 17 were defined as start of study treatment to surgery date from the surgical resection form, greater than 17 weeks. An exact Clopper-Pearson lower 95% confidence limit was used to test the null hypothesis that the pCR rate is ≤30%.
All toxicities were graded according to the NCI-CTCAE version 4.03. DLT was defined as any of the following events attributed to APX005M and nivolumab combination: * Grade 4 hematologic toxicity lasting ≥ 7 days (except asymptomatic lymphopenia) * Grade 3 or 4 neutropenia with a single temperature of \>38.3◦ C (101◦ F) or a sustained temperature of ≥38◦ C (100.4◦ F) for more than one hour * Grade 4 thrombocytopenia or Grade ≥3 thrombocytopenia with signs or symptoms of bleeding or requiring platelet transfusion * Grade 4 non-hematologic toxicity * Grade 3 non-hematologic toxicity lasting \>3 days despite optimal supportive care * Any Grade ≥ 3 non-hematologic laboratory value if: medical intervention is required to treat the subject, abnormality leads to hospitalization, or abnormality persists for \>1 week * Failure to recover from a treatment-related AE to baseline or ≤ Grade 1 within 12 weeks of last dose of investigational product * Grade 5 toxicity.
Establish the MTD dose of APX005M combined with 360 mg of nivolumab for which for which \< 33% of DLT- evaluable participants experience a DLT. In Phase 1b, the RP2D was based on the overall safety and tolerability of the combination of APX005M and nivolumab by testing increasing doses up to 0.3 mg/kg APX005M + nivolumab.
ORR defined as the rate of patients who show as best overall response; either a complete response (CR) or a partial response (PR). The ORR can be evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. using computed tomography (CT) scans/magnetic resonance imaging (MRI). Per RECIST v1.1, for target lesions and assessed by imaging: Complete Response, (CR), Disappearance of all target lesions and nontarget (NT) lesions; Partial Response (PR), \>30% decrease in the sum of the longest diameter of target lesions and no PD in NT lesions or new lesions; Objective Response Rate (ORR)=CR + PR.
The rate of DLTs will be assessed in approximately 56 subjects. DLTs will include Grade 4 neutropenia, anemia, thrombocytopenia, Grade 3or 4 nausea, cytokine release syndrome and other Grade 3 non-hematological toxicity
Incidence and severity of AEs and specific laboratory abnormalities graded according to NCI-CTCAE, v4.03
| Arm | Type | Description |
|---|---|---|
| APX005M With Standard of Care Chemoradiation | EXPERIMENTAL | Participants will receive standard of care chemoradiation, consisting of: * External beam radiation in daily fractions (28 fractions) from Weeks 1-6, administered once per day up to 5 days/week. * Carboplatin (area under the carboplatin plasma concentration versus time curve = 2) and paclitaxel (50 mg/m\^2) chemotherapy intravenously (IV) over 1 hour, once weekly, from Weeks 1-5. The participants also will receive concurrent 0.3 mg/kg APX005M IV over 1 hour, once weekly, on Weeks 1, 2, 4, and 6 (2-3 days after chemoradiation). Surgical resection of the tumor will be planned from Week 10 up to approximately Week 17, as indicated in the protocol amendment under which each participant is enrolled. |
| Phase 1b escalation 0.03 mg/kg | EXPERIMENTAL | Non-small cell lung cancer (NSCLC) or metastatic melanoma APX005M 0.03 mg/kg and nivolumab 360 mg every 3 weeks |
| Phase 1b escalation 0.1 mg/kg | EXPERIMENTAL | Non-small cell lung cancer (NSCLC) or metastatic melanoma APX005M 0.1 mg/kg and nivolumab 360 mg every 3 weeks |
| Phase 1b escalation 0.3 mg/kg | EXPERIMENTAL | Non-small cell lung cancer (NSCLC) or metastatic melanoma APX005M 0.3 mg/kg and nivolumab 360 mg every 3 weeks |
| Phase 2 expansion Cohort 1 | EXPERIMENTAL | Immunotherapy naïve, metastatic or locally advanced NSCLC APX005M 0.3 mg/kg and nivolumab 360 mg every 3 weeks |
| Phase 2 expansion Cohort 2 | EXPERIMENTAL | Metastatic melanoma progressing during treatment with anti-PD-1/PD-L1 therapy APX005M 0.3 mg/kg and nivolumab 360 mg every 3 weeks |
| Phase 2 expansion Cohort 3 | EXPERIMENTAL | Metastatic or locally advanced NSCLC progressing during treatment with anti-PD-1/PD-L1: * Group A: best response of progressive disease or with stable disease \< 16 weeks * Group B: tumor response or with stable disease ≥ 16 weeks |
| APX005M every 3 week | EXPERIMENTAL | Subjects receive APX005M intravenously every 3 week until disease progression, unacceptable toxicity or death. |
| APX005M every 2 week | EXPERIMENTAL | Subjects receive APX005M intravenously every 2 week until disease progression, unacceptable toxicity or death. |
| APX005M every 1 week | EXPERIMENTAL | Subjects receive APX005M intravenously every 1 week until disease progression, unacceptable toxicity or death. |
| Name | Type | Description |
|---|---|---|
| APX005M | DRUG | APX005M IV infusion |
| Radiation Therapy | RADIATION | Radiation therapy, total dose 5040cGy in 180cGy fractions |
| Paclitaxel | DRUG | Paclitaxel IV infusion |
| Carboplatin | DRUG | Carboplatin IV infusion |
| Surgical resection of tumor | PROCEDURE | Surgical removal of the tumor will occur between weeks 10-17 |
| Nivolumab | DRUG | Nivolumab is an immune checkpoint (PD-1) blocking antibody |
Inclusion Criteria: 1. Age ≥ 18 years of age. 2. Histologically proven squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the esophagus or GE junction. 3. Surgically resectable (T1-3 Nx preferably by endoscopic ultrasound \[EUS\]). (Excluded: T1N0 tumors, cervical esophageal l...
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APX005M is an investigational small molecule being studied for the treatment of cancer, including esophageal cancer. It has been evaluated in clinical trials for conditions such as non-small cell lung cancer, melanoma, urothelial carcinoma, MSI-H cancer, and head and neck cancer. APX005M is not yet approved and remains in clinical development.
APX005M is a CD40 agonistic monoclonal antibody, meaning it targets the CD40 receptor. By agonizing CD40, it is designed to stimulate the immune system to fight cancer. This mechanism is being explored in oncology, particularly in combination with other therapies like nivolumab.
APX005M is being developed by Pyxis Oncology, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol PYXS. Pyxis Oncology is advancing APX005M through clinical trials for various cancer indications.
APX005M has completed Phase 1 and Phase 2 clinical trials. It is an investigational drug and has not received FDA approval. The completed trials include a Phase 1 study of APX005M as a monotherapy and a Phase 1 study in combination with nivolumab, as well as a Phase 2 study in esophageal cancer.
APX005M has been studied in three completed clinical trials. NCT02482168 was a Phase 1 study of APX005M alone in patients with various cancers. NCT03123783 was a Phase 1 trial combining APX005M with nivolumab. NCT03165994 was a Phase 2 trial of APX005M with chemoradiation for esophageal cancer.
Yes, APX005M is also known as sotigalimab. In clinical trial NCT03123783, the drug is referred to as 'CD40 Agonistic Antibody APX005M (Sotigalimab)'. This alternative name is used in research and clinical contexts, and both names refer to the same investigational drug.