Ak157d1 For Injection
Advanced Solid Tumors
Phase I
Not Yet Recruiting
A Study of AK157D1 for Injection in Advanced Solid Tumors
Sep 21, 2026
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Nivolumab, Cadonilimab, Capox Regimen
Gastric / Gastroesophageal Junction Adenocarcinoma
Phase III
Recruiting
Phase 3 Study of Cadonilimab Combined With Chemotherapy vs Chemotherapy in Combination With or Without Nivolumab for the 1L Treatment of Participants With HER2-negative, Previously Untreated, Unresectable or Metastatic Gastric/GEJ Adenocarcinoma
Jul 08, 2026
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Akeso, Inc. (AKESF) have in its pipeline
AKESF is currently developing the following drugs: Ak157d1 For Injection, Nivolumab, Cadonilimab, Capox Regimen, Osimertinib, Ak146d1 For Injection, Platinum Chemotherapy, Ak112 Injection. These drug candidates are in various stages of clinical development as the company works toward FDA approval.