SLC-3010 + Gemcitabine for Solid Cancers

Recruiting at 16 trial locations

Overseen By Karen Yu, M.S.

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Selecxine

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Active infection, Cardiovascular disease, Autoimmune disease, others

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

Compensation: Varies

Number of Visits: 1

Duration: Varies by participant

420 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a Phase 1/2, open-label, multicenter, dose escalation and expansion study, evaluating the safety, tolerability, pharmacokinetic, preliminary anti-tumor activity, and effects on pharmacodynamic markers following administration of SLC-3010 as monotherapy and in combination with gemcitabine, in patients with various advanced solid tumors.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that you should not have received any systemic anticancer therapy within 3 weeks before the first dose of the study drug. It's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug Gemcitabine for solid cancers?

Gemcitabine has shown significant antitumor activity in various solid tumors, including non-small cell lung cancer, breast cancer, and pancreatic cancer, with response rates ranging from 11% to 33%. It is effective both as a single agent and in combination with other drugs, and it has been associated with improvements in clinical symptoms and manageable side effects. ^{1 2 3 4 5}

What safety information is available for the treatment SLC-3010 + Gemcitabine?

Gemcitabine, also known as Gemzar, has been studied for safety in various cancers. Common side effects include low blood counts, nausea, and tiredness, but these are usually mild. Serious side effects like lung inflammation are rare, so careful monitoring is advised. ^{1 6 7 8 9}

What makes the drug SLC-3010 + Gemcitabine unique for treating solid cancers?

The combination of SLC-3010 with gemcitabine is unique because it explores a new potential synergy between SLC-3010, a novel agent, and gemcitabine, which is already known for its effectiveness and mild toxicity in various cancers. This combination could offer a new treatment option for solid cancers, potentially enhancing efficacy while maintaining a favorable safety profile. ^{10 11 12 13 14}

Research Team

Sunmi Shin, BSN

Principal Investigator

Project Manager

Yunjeong Jeong, M.S.

Principal Investigator

Project Associate

Sunmi Shin

Principal Investigator

Project Manager

Eligibility Criteria

Adults over 18 with advanced solid tumors that can't be removed by surgery or have spread, and who've tried standard treatments without success or can't receive them. They must be in good enough health to participate, not pregnant or breastfeeding, use effective birth control, and have a life expectancy of at least 3 months.

Inclusion Criteria

I am not using any form of birth control that is listed as unacceptable for this study.

Birth control methods unacceptable for this study include the following:

I have had both of my fallopian tubes surgically closed.

Exclusion Criteria

- QT interval corrected for heart rate using Fridericia's formula > 480 msec at screening

Is currently participating in or has participated in an interventional clinical trial with last dose of the investigational compound or device within 3 weeks of the first dose of treatment in this current trial. Patients who are in survival follow up can be enrolled if the last dose was 3 weeks earlier

I have no other cancers except for cured ones, skin cancers, or completely removed in-situ cancers.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SLC-3010 as monotherapy or in combination with gemcitabine in 21-day cycles

Varies by participant

1 visit per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Gemcitabine
• SLC-3010

Trial Overview The trial is testing SLC-3010 alone and combined with gemcitabine to see how safe they are, what side effects they cause, how the body processes them, and their preliminary effectiveness against various advanced solid tumors.

Participant Groups

Group I: Monotherapy Experimental Treatment 1 Intervention

SLC-3010 Intravenous infusion over 30 minutes on day 1 of each 21-day cycle

Group II: Gemcitabine combination Experimental Treatment 2 Interventions

SLC-3010 Intravenous infusion over 30 minutes on day 1 of each 21-day cycle Gemcitabine 1000 ㎎/㎡ Intravenous infusion over 30 minutes on day 1 and 8 of each 21-day cycle

Who Is Running the Clinical Trial?

Selecxine

Lead Sponsor

Trials

1

Recruited

420+

Findings from Research

In a study of 82 patients with advanced non-small-cell lung cancer, gemcitabine demonstrated efficacy with a 20% partial response rate and a median survival duration of 7 months, while also improving disease-related symptoms in 70% of patients.

The treatment was generally safe, with mostly mild and reversible side effects, and low rates of severe toxicity, indicating that gemcitabine could be a promising option for further research in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-agent activity of weekly gemcitabine in advanced non-small-cell lung cancer: a phase II study. Anderson, H., Lund, B., Bach, F., et al.[2022]

Gemcitabine is a highly valuable chemotherapeutic agent for treating both early and advanced non-small cell lung cancer (NSCLC), showing a tumor regression rate of about 20% in patients, regardless of their previous chemotherapy history.

It is particularly effective in combination with platinum-based therapies and can be safely administered alongside radiotherapy, making it a key component in multimodal treatment strategies for NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gemcitabine (Gemzar) in non-small cell lung cancer. Manegold, C.[2022]

Oral gemcitabine was generally well-tolerated in a study of 30 patients with advanced cancer, with moderate gastrointestinal toxicities reported, and the maximum tolerated dose was not reached.

Despite low systemic exposure to gemcitabine due to extensive first-pass metabolism, one patient showed stable disease for over 2 years, suggesting potential antitumor activity that merits further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral administration of gemcitabine in patients with refractory tumors: a clinical and pharmacologic study. Veltkamp, SA., Jansen, RS., Callies, S., et al.[2022]

Gemcitabine is effective in treating advanced breast cancer, both alone and in combination with other drugs, due to its unique mechanisms that disrupt DNA synthesis, as supported by various small trials and preclinical models.

Promising results from neoadjuvant studies indicate that gemcitabine combinations may lead to higher pathologic complete response rates, which are linked to improved survival, paving the way for larger phase III trials to further evaluate its efficacy compared to standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gemcitabine in breast cancer: future directions. Tripathy, D.[2022]

Gemcitabine is an effective chemotherapy drug that shows significant antitumor activity against various solid tumors, including bladder, breast, ovarian, and pancreatic cancers, with response rates ranging from 11% to 33% in phase I trials.

When combined with other DNA-damaging agents like cisplatin, gemcitabine has demonstrated even higher response rates of 42%-54% in non-small cell lung cancer (NSCLC), suggesting it is a valuable treatment option for chemoresistant cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gemcitabine: Future Prospects of Single-Agent and Combination Studies. van Moorsel CJ, ., Peters, GJ., Pinedo, HM.[2019]

In a late phase II study involving 73 patients with untreated non-small-cell lung cancer (NSCLC), LY188011 (gemcitabine hydrochloride) demonstrated an efficacy response rate of 26%, indicating it can be a viable treatment option for this type of cancer.

The safety profile of LY188011 was generally favorable, with most adverse reactions being mild (grade 1 or 2), although careful monitoring is necessary due to a reported death from interstitial pneumonia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Late phase II study of LY188011 (gemcitabine hydrochloride) in patient with non-small-cell lung cancer. Gemcitabine Late Phase II Cooperative Study Group A)]. Fukuoka, M., Negoro, S., Kudo, S., et al.[2022]

The combination of sorafenib and gemcitabine was found to be well tolerated in a study involving 42 patients with advanced solid tumors, with a recommended dose of sorafenib at 400 mg twice daily and gemcitabine at 1,000 mg/m2.

Antitumor activity was observed, with 10.5% of patients showing partial responses in ovarian cancer and 63.2% achieving disease stabilization in the dose-escalation part, indicating potential efficacy for further evaluation in pancreatic and ovarian cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I trial of sorafenib and gemcitabine in advanced solid tumors with an expanded cohort in advanced pancreatic cancer. Siu, LL., Awada, A., Takimoto, CH., et al.[2022]

This phase I trial involving 16 patients with advanced pancreatic cancer demonstrated that the combination of M2ES (a novel endostatin) and gemcitabine was well tolerated, with no dose-limiting toxicities observed.

The treatment resulted in a stable disease rate of 40%, with particularly promising results at a lower dose of M2ES (7.5 mg/m2), where 75% of patients showed stable disease, indicating potential efficacy in this difficult-to-treat cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I trial of M2ES, a novel polyethylene glycosylated recombinant human endostatin, plus gemcitabine in advanced pancreatic cancer. Chen, Y., DU, Y., Li, P., et al.[2021]

Gemcitabine, a nucleoside analogue, shows promising activity when combined with carboplatin for treating non-small cell lung cancer, although some patients experienced dose-limiting myelotoxicity.

In studies involving recurrent ovarian cancer and refractory solid tumors, gemcitabine combined with paclitaxel demonstrated manageable toxicities and allowed for dose escalation, indicating potential for effective treatment regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I studies of gemcitabine combined with carboplatin or paclitaxel. Pedersen, AG.[2022]

In a study of 49 patients with advanced non-small-cell lung cancer (NSCLC) who had previously failed chemotherapy, the combination of paclitaxel and gemcitabine showed an overall response rate of 18%, with one complete response and eight partial responses, indicating some efficacy as a salvage treatment.

The treatment was generally well-tolerated, with manageable side effects; however, 12% of patients experienced severe neutropenia, and 32% had significant neurotoxicity, suggesting that while effective, careful monitoring for side effects is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Salvage treatment with paclitaxel and gemcitabine for patients with non-small-cell lung cancer after cisplatin- or docetaxel-based chemotherapy: a multicenter phase II study. Androulakis, N., Kouroussis, C., Kakolyris, S., et al.[2022]

Gemcitabine has established therapeutic value in treating various cancers, but its potential in epidermoid tumors of the upper aero-digestive tract and uterine cervix has not been fully explored despite these tumors being sensitive to treatment.

The authors suggest that further research and combination studies involving gemcitabine in these specific tumor models could be beneficial, as they have been somewhat overlooked in modern oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Role of gemcitabine in the treatment of other malignant tumors]. Clippe, C., Ligneau, B., Trillet-Lenoir, V.[2022]

Neoadjuvant chemotherapy, including gemcitabine combined with anthracyclines and taxanes, is becoming standard for treating locally advanced breast cancer and may improve surgical options for earlier-stage patients.

Preliminary results from phase II trials indicate that gemcitabine combined with doxorubicin or paclitaxel leads to higher complete response rates and is well-tolerated, suggesting it could enhance treatment outcomes for breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neoadjuvant gemcitabine therapy for breast cancer. Sánchez-Rovira, P., Jaén, A., Dueñas, R., et al.[2022]

Gemcitabine (GEMZAR) has shown to be an effective treatment for non-small-cell lung cancer (NSCLC) with a response rate of about 21% as a single agent, and it has a mild toxicity profile, making it suitable for combination therapies.

When combined with cisplatin, gemcitabine achieved higher response rates ranging from 38% to 54% and median survival times of 8.4 to 14.3 months, with manageable side effects, indicating its potential as a preferred treatment option in NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination studies with gemcitabine in the treatment of non-small-cell lung cancer. Steward, WP.[2022]

In a study of 83 patients with advanced non-small-cell lung cancer (NSCLC), gemcitabine demonstrated significant activity, with 19% of patients achieving a partial response and a median response duration of 29 weeks.

The treatment was well tolerated, with manageable side effects such as leukopenia and thrombocytopenia occurring in 23% and 20% of patients, respectively, indicating that gemcitabine could be a viable second-line treatment option for patients who previously responded to platinum-based chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gemcitabine as second-line treatment for advanced non-small-cell lung cancer: A phase II trial. Crinò, L., Mosconi, AM., Scagliotti, G., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Single-agent activity of weekly gemcitabine in advanced non-small-cell lung cancer: a phase II study. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Gemcitabine (Gemzar) in non-small cell lung cancer. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Oral administration of gemcitabine in patients with refractory tumors: a clinical and pharmacologic study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Gemcitabine in breast cancer: future directions. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Gemcitabine: Future Prospects of Single-Agent and Combination Studies. [2019]

6. Japan pubmed.ncbi.nlm.nih.gov

[Late phase II study of LY188011 (gemcitabine hydrochloride) in patient with non-small-cell lung cancer. Gemcitabine Late Phase II Cooperative Study Group A)]. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Phase I trial of sorafenib and gemcitabine in advanced solid tumors with an expanded cohort in advanced pancreatic cancer. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Phase I trial of M2ES, a novel polyethylene glycosylated recombinant human endostatin, plus gemcitabine in advanced pancreatic cancer. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Phase I studies of gemcitabine combined with carboplatin or paclitaxel. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Salvage treatment with paclitaxel and gemcitabine for patients with non-small-cell lung cancer after cisplatin- or docetaxel-based chemotherapy: a multicenter phase II study. [2022]

11. France pubmed.ncbi.nlm.nih.gov

[Role of gemcitabine in the treatment of other malignant tumors]. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Neoadjuvant gemcitabine therapy for breast cancer. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Combination studies with gemcitabine in the treatment of non-small-cell lung cancer. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Gemcitabine as second-line treatment for advanced non-small-cell lung cancer: A phase II trial. [2022]