What side effects are associated with this type of intervention?

The most common treatments for pancreatic cancer, such as gemcitabine and nab-paclitaxel, are associated with several side effects. These include neutropenia (a decrease in white blood cells), fatigue, neuropathy (nerve damage causing pain or numbness), nausea, diarrhea, and thrombocytopenia (a decrease in platelets). When combined with new therapeutic agents like SOT102, which target cancer cells to enhance chemotherapy effects, additional side effects may include infusion-related reactions and potential immune system-related effects. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer that involve targeting cancer cells and enhancing the effects of standard chemotherapy. Notably, gemcitabine was approved for first-line therapy of metastatic pancreatic cancer due to its significant improvements in clinical benefit and survival. Additionally, the combination of gemcitabine with nanoparticle albumin-bound paclitaxel (nab-paclitaxel) has shown a clear survival benefit over single-agent gemcitabine. These treatments align with the approach being studied in the SOT102 trial, which combines a new therapeutic agent with standard chemotherapy to potentially enhance treatment efficacy.

What other types of research exist?

Promising novel alternatives to SOT102 for pancreatic cancer patients in 2024 include: 1) Gemtuzumab ozogamicin, which has shown benefit in acute myeloid leukemia and may have potential in other cancers; 2) Pembrolizumab, an immune checkpoint inhibitor that has shown efficacy in various cancers including non-small cell lung cancer; 3) Lutetium-177-PSMA-617, a radioligand therapy that has shown promise in prostate cancer and may be explored for pancreatic cancer; 4) Surufatinib, a tyrosine kinase inhibitor that has demonstrated efficacy in neuroendocrine tumors and could be considered for pancreatic cancer. These therapies represent cutting-edge approaches that could complement or enhance the effects of standard chemotherapy.

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Antibody Drug Conjugate

SOT102 for Gastric and Pancreatic Adenocarcinoma (CLAUDIO-01 Trial)

Phase 1 & 2

Recruiting

Led By Josep Tabernero, M.D., Ph.D.

Research Sponsored by SOTIO Biotech a.s.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of the patient's signing the icf until the end of the trial, assessed up to approximately 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called SOT102 to treat patients with advanced or metastatic pancreatic cancer. It aims to find the best dose and see how well the drug works alone or with other standard treatments.

Who is the study for?

This trial is for adults with advanced or metastatic gastric or pancreatic adenocarcinoma. They must have tried at least two prior therapies (one for pancreatic cancer), not be pregnant, and agree to contraception. Excluded are those with severe preexisting conditions, recent major surgery, certain lung diseases, active infections, HIV/hepatitis B/C, or specific genetic deficiencies.

What is being tested?

The trial tests SOT102 alone (Part A) and combined with standard chemotherapy (nab-paclitaxel/gemcitabine; Part B). It aims to find the maximum tolerated dose and recommended phase 2 dose of SOT102 as well as its effectiveness both alone (Part C) and in combination therapy (Part D).

What are the potential side effects?

Potential side effects of SOT102 may include typical reactions associated with antibody drug conjugates such as fatigue, nausea, allergic reactions at the infusion site. The exact side effects will be further identified during the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of the patient's signing the icf until the end of the trial, assessed up to approximately 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of the patient's signing the icf until the end of the trial, assessed up to approximately 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of the patient's signing the icf until the end of the trial, assessed up to approximately 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Parts A and B: The definition of the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of SOT102 given as monotherapy and in combination with first-line SoC treatment

Parts C and D: The assessment of the efficacy of SOT102 in monotherapy and in combination with first-line SoC treatment

Secondary study objectives

Part C (monotherapy): Clinical benefit rate (CBR) according to RECIST 1.1

Parts A and B (monotherapy and combination with SoC): Characterization of pharmacokinetics (PK) of total SOT102 and its derivates

Parts A and B (monotherapy and combination with SoC): Evidence of SOT102 activity in monotherapy in individual patients

+24 more

Other study objectives

Parts C and D (monotherapy and combination with SoC): Relationship between the intensity of CLDN18.2 expression and clinical outcome

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: SOT102Experimental Treatment1 Intervention

SOT102 is administered as intravenous infusion over 45 minutes as monotherapy or in combination with established standard of care therapy, every 14 days until the disease progression or intolerance to SOT102. SoC therapy is administered as per approved local standards. Patients will receive premedication with corticosteroids (4 mg dexamethasone twice daily) the day before, the day of (at least one hour prior), and the day after each SOT102 administration. Starting dose of SOT102 is 0.032 mg/kg. Dose levels are to be escalated according modified Fibonacci scheme.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for pancreatic cancer, such as FOLFIRINOX and gemcitabine plus nab-paclitaxel, work by disrupting cancer cell division and DNA repair mechanisms, leading to cell death. The new therapeutic agent SOT102, being studied in clinical trials, is an antibody-drug conjugate that targets specific markers on cancer cells to deliver cytotoxic agents directly to the tumor. This targeted approach aims to enhance the effectiveness of standard chemotherapy while potentially reducing side effects, offering a promising advancement for pancreatic cancer patients.