SG2501 for Blood Cancers and Lymphoma

Recruiting at 7 trial locations

Overseen By Nashat Gabrail, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Hangzhou Sumgen Biotech Co., Ltd.

Must not be taking: Anticancer, Corticosteroids, Antiviral, others

Disqualifiers: CNS metastases, Cardiac disease, HIV, others

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

Compensation: Varies

Number of Visits: Unknown

2 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that anticancer therapy should be stopped within 5 half-lives or 4 weeks before the study, and certain medications like hydroxyurea may be used during the trial. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug SG2501 for blood cancers and lymphoma?

Research on similar treatments, like SGN-35, shows that these types of drugs can shrink tumors and help patients with certain types of lymphoma, suggesting that SG2501 might work in a similar way. ^{1 2 3 4 5}

What safety data exists for SG2501 in humans?

SG2501, also known as SGN-CD70A, was tested in a study for certain types of lymphoma. The most common side effects were low platelet counts (thrombocytopenia), nausea, anemia, and fatigue. The study found that the treatment could cause significant drops in platelet levels, which are important for blood clotting. ^{3 6 7 8 9}

What is the purpose of this trial?

This trial is testing a new drug called SG2501 to see if it is safe and effective for patients with certain blood cancers that have come back or did not respond to previous treatments. The study will find the best dose and check if the drug can help the immune system fight the cancer.

Eligibility Criteria

Adults with certain blood cancers or lymphoma that haven't responded to previous treatments can join this trial. They must be willing to use contraception and have a life expectancy of at least 12 weeks. Key organ functions need to be adequate, and they should not have had major surgery recently or any other serious medical conditions that could interfere with the study.

Inclusion Criteria

Baseline Left Ventricular Ejection Fraction (LVEF) ≥ 50%

My liver is functioning well.

Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures

Exclusion Criteria

I have active tuberculosis.

I have not had major surgery in the last 4 weeks.

I have active hepatitis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase Ia

Phase Ia consists of an accelerated titration using single patient cohorts to evaluate SG2501 at lower dose levels, followed by dose-escalation using multipatient cohorts to establish a maximum tolerated dose (MTD).

24 weeks

Weekly doses

Treatment Phase Ib

Phase Ib consists of dose expansion cohorts with SG2501 monotherapy in subjects with relapsed or refractory multiple myeloma (MM) or diffuse large B-cell lymphoma (DLBCL).

24 weeks

Weekly doses

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• SG2501

Trial Overview SG2501 is being tested in adults with relapsed or refractory hematological malignancies and lymphoma. This early-phase trial will gradually increase doses to find safe levels, understand how the body processes the drug, check for preliminary signs of effectiveness, and explore potential biomarkers.

Participant Groups

Group I: SG2501 Experimental Treatment 1 Intervention

SG2501 monotherapy intravenous (IV) infusion - Weekly doses

Who Is Running the Clinical Trial?

Hangzhou Sumgen Biotech Co., Ltd.

Lead Sponsor

Trials

7

Recruited

770+

Findings from Research

In a study of 502 patients with newly diagnosed follicular lymphoma, higher pretreatment levels of serum soluble interleukin-2 receptor (sIL-2R) were linked to worse overall survival, disease-specific survival, and progression-free survival outcomes.

The research demonstrated a clear dose-dependent relationship, indicating that as serum sIL-2R levels increased, the probability of survival decreased, suggesting that sIL-2R could be a valuable prognostic marker for treatment outcomes in follicular lymphoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pretreatment serum soluble interleukin-2 receptor level predicts survival in patients with newly diagnosed follicular lymphoma. Nozaki, K., Sugahara, H., Ueda, S., et al.[2022]

SGN-35, an antibody-drug conjugate targeting CD30, effectively releases the potent drug MMAE inside CD30(+) cancer cells, achieving high intracellular concentrations that contribute to its therapeutic effects.

MMAE not only kills CD30(+) cells but can also diffuse to and exert cytotoxic effects on neighboring CD30(-) cells, enhancing the overall antitumor activity of SGN-35 in mixed tumor environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracellular activation of SGN-35, a potent anti-CD30 antibody-drug conjugate. Okeley, NM., Miyamoto, JB., Zhang, X., et al.[2021]

In a Phase 1 study involving 24 patients with refractory Hodgkin lymphoma or CD30(+) non-Hodgkin lymphoma, SGN-30 was found to be safe with mild adverse effects, and the maximum tolerated dose was not reached.

The treatment showed modest clinical activity, with one patient achieving a complete response and six others maintaining stable disease for 6 to 16 months, indicating potential effectiveness in targeting CD30(+) malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 1 multidose study of SGN-30 immunotherapy in patients with refractory or recurrent CD30+ hematologic malignancies. Bartlett, NL., Younes, A., Carabasi, MH., et al.[2021]

SGN-30, a monoclonal antibody targeting CD30+ cancers, shows promise in treating Hodgkin's disease and anaplastic large cell lymphoma by activating growth-regulating pathways and inducing cell growth arrest.

In combination with standard chemotherapy agents, SGN-30 enhances their effectiveness, suggesting it could improve treatment outcomes for patients with CD30+ malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Signaling via the anti-CD30 mAb SGN-30 sensitizes Hodgkin's disease cells to conventional chemotherapeutics. Cerveny, CG., Law, CL., McCormick, RS., et al.[2019]

In a study of 338 patients with chronic lymphocytic leukemia (CLL), those with serum soluble CD23 (sCD23) levels greater than 1000 UI/L exhibited worse clinical outcomes, including a higher likelihood of requiring treatment sooner and lower overall survival rates.

High sCD23 levels were found to be a significant predictor of shorter treatment-free survival and may provide insights into the mechanisms of treatment response and resistance in CLL patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serum soluble CD23 levels are an independent predictor of time to first treatment in chronic lymphocytic leukemia. Piñeyroa, JA., Magnano, L., Rivero, A., et al.[2022]

SGN-CD19B is a promising anti-CD19 antibody drug conjugate that shows improved potency in treating relapsed/refractory B-cell malignancies, inducing cell death through a unique mechanism that causes DNA damage rather than using traditional microtubule inhibitors.

In preclinical studies, SGN-CD19B demonstrated effective and durable tumor regressions at lower doses compared to other antibody drug conjugates, and it was well-tolerated in cynomolgus monkeys, indicating its potential for safe clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic potential of SGN-CD19B, a PBD-based anti-CD19 drug conjugate, for treatment of B-cell malignancies. Ryan, MC., Palanca-Wessels, MC., Schimpf, B., et al.[2021]

In a first-in-human study involving 20 patients with relapsed or refractory CD70-positive non-Hodgkin lymphoma, SGN-CD70A demonstrated modest antitumor activity, achieving 1 complete remission and 3 partial remissions, with some responses lasting over 42 weeks.

However, the treatment was associated with significant adverse effects, particularly thrombocytopenia occurring in 75% of patients, which limited the frequency of dosing and raised safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 1 trial of SGN-CD70A in patients with CD70-positive diffuse large B cell lymphoma and mantle cell lymphoma. Phillips, T., Barr, PM., Park, SI., et al.[2020]

In a phase 1 study involving 16 patients with relapsed/refractory lymphoma, SAR245409 (voxtalisib) demonstrated preliminary efficacy with one complete response and two partial responses, indicating its potential effectiveness in treating this type of cancer.

The treatment was generally well-tolerated, with common side effects including nausea (31.3%) and diarrhea (25.0%), and showed significant inhibition of key cancer pathways, suggesting a mechanism of action that could be beneficial for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, safety, pharmacokinetics and pharmacodynamics of SAR245409 (voxtalisib, XL765), an orally administered phosphoinositide 3-kinase/mammalian target of rapamycin inhibitor: a phase 1 expansion cohort in patients with relapsed or refractory lymphoma. Papadopoulos, KP., Egile, C., Ruiz-Soto, R., et al.[2021]

A study analyzing 2069 reports of sacituzumab govitecan (SG) from the FDA Adverse Event Reporting System found that SG is significantly associated with increased risks of blood lymphatic system disorders and hepatobiliary disorders, indicating important safety concerns for patients.

In addition to common adverse events like anemia and neutropenia, the study identified unexpected significant adverse events such as colitis and meningitis, highlighting the need for ongoing monitoring and safety management in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-marketing safety surveillance of sacituzumab govitecan: an observational, pharmacovigilance study leveraging FAERS database. Liu, W., Du, Q., Guo, Z., et al.[2023]

References

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

Pretreatment serum soluble interleukin-2 receptor level predicts survival in patients with newly diagnosed follicular lymphoma. [2022]

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

Intracellular activation of SGN-35, a potent anti-CD30 antibody-drug conjugate. [2021]

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

A phase 1 multidose study of SGN-30 immunotherapy in patients with refractory or recurrent CD30+ hematologic malignancies. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Signaling via the anti-CD30 mAb SGN-30 sensitizes Hodgkin's disease cells to conventional chemotherapeutics. [2019]

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

Serum soluble CD23 levels are an independent predictor of time to first treatment in chronic lymphocytic leukemia. [2022]

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

Therapeutic potential of SGN-CD19B, a PBD-based anti-CD19 drug conjugate, for treatment of B-cell malignancies. [2021]

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

A phase 1 trial of SGN-CD70A in patients with CD70-positive diffuse large B cell lymphoma and mantle cell lymphoma. [2020]

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

Efficacy, safety, pharmacokinetics and pharmacodynamics of SAR245409 (voxtalisib, XL765), an orally administered phosphoinositide 3-kinase/mammalian target of rapamycin inhibitor: a phase 1 expansion cohort in patients with relapsed or refractory lymphoma. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Post-marketing safety surveillance of sacituzumab govitecan: an observational, pharmacovigilance study leveraging FAERS database. [2023]