SKB264 + Pembrolizumab for Solid Tumors

Not currently recruiting at 47 trial locations

Overseen By Jin Xiaoping

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Klus Pharma Inc.

Disqualifiers: CNS metastases, Cardiovascular diseases, Hepatitis, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 21 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment combination of SKB264 (an experimental treatment) and Pembrolizumab (KEYTRUDA, an immunotherapy drug) to evaluate its effectiveness and safety for people with certain solid tumors. The focus includes cancers such as cervical, urothelial (affecting the urinary system), ovarian, prostate, and advanced endometrial (uterine) cancer. The trial seeks participants with these cancers who have at least one measurable tumor. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research is investigating the safety of combining SKB264 and pembrolizumab for treating certain solid tumors. Previous studies have tested this combination in patients with cervical cancer and other cancer types. These studies aim to assess patient tolerance and identify any serious side effects.

Pembrolizumab, one of the drugs in this combination, has FDA approval for other uses, indicating its well-established safety. The combination with SKB264 remains under study, but its phase 2 trial status suggests some early evidence of sufficient safety for further research. Researchers continue to gather information on patient tolerance and potential side effects.

While early results may be encouraging, joining a clinical trial involves some risk. Responses to treatment vary, so potential participants should discuss any concerns with their healthcare providers. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for solid tumors?

Researchers are excited about SKB264 combined with pembrolizumab because this combination targets solid tumors in a novel way. Unlike traditional chemotherapy, which attacks rapidly dividing cells indiscriminately, SKB264 is an antibody-drug conjugate that delivers a cytotoxic agent directly to cancer cells, potentially reducing side effects. Pembrolizumab, an immunotherapy, works by unleashing the immune system to attack cancer cells more effectively. Together, they offer a dual approach: targeting the tumor directly while also enhancing the body's natural defenses. This innovative combination could lead to more effective and less toxic treatment options for patients with solid tumors.

What evidence suggests that this trial's treatments could be effective for solid tumors?

Research has shown that Pembrolizumab effectively treats various solid tumors by helping the immune system identify and attack cancer cells. Patients with cancers similar to those in this study have responded well to Pembrolizumab. In this trial, participants will receive a combination of SKB264 and Pembrolizumab. Researchers are testing SKB264 because it targets specific proteins on cancer cells, potentially enhancing the immune response when combined with Pembrolizumab. Early results suggest that this combination could be particularly effective for treating solid tumors, including cervical, bladder, ovarian, prostate, and advanced endometrial cancers. Although the effectiveness of this combination is still under study, its mechanism provides a strong basis for expecting positive outcomes. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for people with certain advanced cancers (cervical, urothelial, ovarian, prostate) who are in good physical condition and expected to live at least 3 more months. They should have a measurable tumor and be able to provide tissue samples. Participants need decent organ and bone marrow function and must have recovered from previous therapy side effects.

Inclusion Criteria

My ovarian cancer has come back.

I am fully active or can carry out light work.

Subjects with expected survival ≥ 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SKB264 in combination with Pembrolizumab by intravenous administration

21 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pembrolizumab
• SKB264

Trial Overview The study tests the effectiveness and safety of combining two drugs: SKB264 and Pembrolizumab, on patients with specific solid tumors. It aims to see how well these drugs work together in treating different types of cancer by measuring changes in tumor size.

How Is the Trial Designed?

Group I: cohort D Experimental Treatment 2 Interventions

subjects will receive SKB264 in combination with pembrolizumab by intravenous administration

Group II: cohort C Experimental Treatment 2 Interventions

subjects will receive SKB264 in combination with pembrolizumab by intravenous administration

Group III: cohort B Experimental Treatment 2 Interventions

subjects will receive SKB264 in combination with pembrolizumab by intravenous administration

Group IV: cohort A Experimental Treatment 2 Interventions

subjects will receive SKB264 in combination with pembrolizumab by intravenous administration

Group V: Cohort E Experimental Treatment 2 Interventions

subjects will receive SKB264 in combination with pembrolizumab by intravenous administration

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

Approved in United States as KEYTRUDA for:

• Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
• Melanoma
• Non-small cell lung cancer (NSCLC)
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Hepatocellular carcinoma
• Renal cell carcinoma
• Cervical cancer
• Endometrial carcinoma

Approved in European Union as KEYTRUDA for:

• Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
• Melanoma
• Non-small cell lung cancer (NSCLC)
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Hepatocellular carcinoma
• Renal cell carcinoma
• Cervical cancer
• Endometrial carcinoma

Approved in United Kingdom as KEYTRUDA for:

• Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1

Who Is Running the Clinical Trial?

Klus Pharma Inc.

Lead Sponsor

Trials

4

Recruited

2,100+

Myriad Genetics, Inc.

Industry Sponsor

Trials

18

Recruited

5,700+

Discovery Life Sciences, LLC

Collaborator

Trials

1

Recruited

240+

Ventana Medical Systems, Inc

Collaborator

Trials

1

Recruited

240+

Frontage Laboratories, Inc.

Collaborator

Trials

2

Recruited

270+

Clario

Collaborator

Trials

1

Recruited

30+

Published Research Related to This Trial

In a phase II trial involving 15 patients with resectable non-small cell lung cancer (NSCLC), neoadjuvant treatment with pembrolizumab showed a major pathologic response in 27% of patients, indicating promising antitumor activity before surgery.

The treatment was found to be feasible and safe, with only 33% of patients experiencing moderate adverse events, and no postoperative mortality, suggesting that pembrolizumab does not compromise surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. Eichhorn, F., Klotz, LV., Kriegsmann, M., et al.[2022]

Pembrolizumab (Keytruda) is the first anti-PD-1 therapy approved in the US for treating advanced malignant melanoma, specifically for patients who have progressed after prior treatments.

It is designed to target the PD-1 protein, enhancing the immune system's ability to fight cancer, and is currently under review for approval in the EU.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab: first global approval. Poole, RM.[2021]

Pembrolizumab, an immune checkpoint inhibitor, can cause pneumonitis in 1%-5% of patients, and this case report highlights an atypical presentation of this side effect in a patient with metastatic squamous cell carcinoma.

The patient was successfully treated with steroid therapy after ruling out other potential causes, leading to complete resolution of the pneumonitis, emphasizing the importance of recognizing and managing atypical cases of checkpoint inhibitor-pneumonitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recurrent and atypical immune checkpoint inhibitor-induced pneumonitis. Jeon, WJ., Nguyen, J., Castillo, DR., et al.[2023]

Pembrolizumab, a PD-1 inhibitor, has demonstrated clinical effectiveness in treating various solid tumors, particularly in patients with PD-L1-positive non-small-cell lung cancer and unresectable/metastatic melanoma.

Early-phase trials and ongoing studies are focused on further confirming the clinical benefits of pembrolizumab in thoracic malignancies, highlighting its potential as a significant treatment option in cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. Karim, S., Leighl, N.[2017]

Pembrolizumab (KEYTRUDA) was approved by the FDA for treating advanced melanoma, showing an overall response rate of 24% in a trial of 89 patients, with 86% of responses lasting at least 6 months.

While there are potential immune-mediated side effects, the benefits of prolonged tumor response durations were deemed to outweigh these risks, marking an improvement over existing treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. Chuk, MK., Chang, JT., Theoret, MR., et al.[2021]

Pembrolizumab, a PD-1 inhibitor used in cancer treatment, can lead to rare but serious immune-related adverse events, including type 1 diabetes mellitus, occurring in about 0.2% of cases.

A review of 42 cases revealed that patients may develop diabetic ketoacidosis during treatment, highlighting the need for blood glucose monitoring and awareness of this potential side effect among clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Programmed Cell Death-1 Inhibitor-Induced Type 1 Diabetes Mellitus. Clotman, K., Janssens, K., Specenier, P., et al.[2022]

Pembrolizumab (Keytruda) was approved by the FDA for treating metastatic non-small cell lung cancer (mNSCLC) in patients with tumors expressing PD-L1, showing significant improvements in overall survival (OS) and progression-free survival (PFS) in two major clinical trials with thousands of participants.

In the KEYNOTE-024 trial, pembrolizumab demonstrated a 40% reduction in the risk of death compared to chemotherapy, while in the KEYNOTE-010 trial, it also showed a significant survival advantage over chemotherapy in patients who had previously progressed on treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non-Small Cell Lung Cancer: First-Line Therapy and Beyond. Pai-Scherf, L., Blumenthal, GM., Li, H., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06483334

NCT06483334 | A Study of Efficacy and Safety ... This study is a substudy being conducted under one pembrolizumab umbrella master study KEYMAKER-U04. The substudy will consist of 2 parts.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05642780

Study Details | NCT05642780 | SKB264 in Combination ... The purpose of this study is to evaluate the efficacy and safety of combination of SKB264 and Pembrolizumab in patients with selected solid tumors including ...

3. onclive.com onclive.com/view/sacituzumab-tirumotecan-plus-pembrolizumab-is-set-to-be-evaluated-in-tnbc

Sacituzumab Tirumotecan Plus Pembrolizumab Is Set to ... Sacituzumab tirumotecan plus pembrolizumab is currently being evaluated for select patients with TNBC in the phase 3 TroFuse-012 trial.

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.5_suppl.796

Report from the phase 1/2 MK-2870-001 study. No treatment-related deaths were reported by safety data cutoff (May 21, 2024). Efficacy outcomes are shown in the Table. Conclusions: sac ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12142944/

Results of a phase 1/2 study of sacituzumab tirumotecan in ... We report results from the phase 1 dose-escalation cohorts in advanced solid tumors and phase 2 expansion cohorts for metastatic triple-negative breast cancer ...

6. merck.com merck.com/news/merck-advances-oncology-innovation-highlighting-progress-in-new-tumor-types-and-earlier-stages-of-disease-at-esmo-2025/

Merck Advances Oncology Innovation, Highlighting ... Efficacy and safety data from the Phase 1/2 MK-2870-001 study evaluating sac-TMT for patients with advanced or metastatic cervical cancer ( ...

7. merckclinicaltrials.com merckclinicaltrials.com/trial/nct06170788/

MK-2870 in Combination With Pembrolizumab Versus ... The primary objective of the study is to compare sacituzumab tirumotecan combined with pembrolizumab to pembrolizumab alone with respect to overall survival ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06706219

NCT06706219 | Efficacy and Safety of SKB264 in ... This study is a phase 2 open-label, multicenter clinical study to evaluate the efficacy and safety SKB264 in combination with pembrolizumab in patients with ...